Binge DrinkingNCT03224416
Individual and Contextual Factors That Influence Sexual Decisions
A study testing Alcohol Administration and No Alcohol Administration in people with Binge Drinking and Unsafe Sex, run by Brown University at 1 site in United States.
Trial summary
For decades, men who have sex with men (MSM) have carried the heaviest burden associated with the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately 4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV infections among males. Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking, Unsafe Sex, HIV/AIDS
- What is being tested?
- Alcohol Administration and No Alcohol Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- single (i.e., not in a mutually monogamous relationship for at least 3 months)
- sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months
- have had condomless anal sex with a male partner in their lifetime
- have had at least one sexual encounter with a male partner met online in their lifetime
- characterized as a current heavy drinker, as defined by self-report of one or more episodes of heavy drinking (i.e., ≥5 standard drinks in a single occasion) during the past 30 days; and 5) HIV negative, based on self-report.
Who cannot join
- Non-drinkers and light to moderate drinkers
- Individuals with current alcohol problems (as indexed by an AUDIT score ≥16)
- Individuals with current drug problems (as indexed by a DAST score ≥6)
- Females (as this is a study of men who have sex with men).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912
Mark A Celio, Ph.D., 401-863-6662, mark_celio@brown.edu
Jamie Hendrickson, 4018636665, jamie_hendrickson@brown.edu
About this study
Official title: Effects of Acute Alcohol on Sex-Specific Delay Discounting and Subsequent Sexual Decision Making Among MSM
For decades, men who have sex with men (MSM) have carried the heaviest burden associated with the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately 4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV infections among males. Furthermore, the estimated number of new HIV infections attributed to male-to-male sexual contact is currently rising. In order to improve interventions to decrease transmission of HIV among MSM, it is important to have a better understanding of predictors of risky sexual behavior. Alcohol use is among the most reliable predictors of risky sexual behavior. Unfortunately, studies of alcohol use and risky sex among MSM have mainly relied on survey-based methods that cannot advance our understanding of the causal mechanisms linking acute alcohol use to HIV risk behavior.
This study will utilize an "alcohol/placebo/nonalcohol" design to examine the mechanisms underlying the association between the acute effects of alcohol (i.e., pharmacological and expectancy) and risky sexual decision making in MSM. Focal mechanisms include sex-specific delay discounting (SSDD), and the core constructs of the Cognitive Mediation Model. The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. This 3-group design will enable us to test the pharmacological effects of alcohol while accounting for potential expectancy effects. Participants (Target N = 150-180) will be randomly assigned to one condition; all will undergo the same protocol, which will be completed within one experimental session. The study protocol consists of baseline assessment, followed by beverage administration, followed by post-drinking assessment of SSDD and sexual decision making, followed by debriefing.
Read the detailed description
Significance and Specific Aims of Project
Men who have sex with men (MSM) continue to be disproportionately affected by the HIV epidemic in the United States. However, the experimental research designed to advance our knowledge of the causal link between alcohol use and risky sex has disproportionately focused on heterosexual men and women. Experimental studies are needed to test established theories and explore new mechanisms linking alcohol to HIV risk among MSM. This proposed project will experimentally test if sex-specific delay discounting (SSDD) is a mechanism of action underlying the association between alcohol and risky sexual behavior among MSM. More specifically stated, the aims are to:
- Examine the pharmacological effect of alcohol on sex-specific delay discounting in MSM, with the prediction that individuals who consume alcohol will display greater sexual impulsivity
- Examine the expectancy effect of alcohol on sex-specific delay discounting in MSM, with the prediction that those who receive placebo will evince greater sexual impulsivity than true controls
- Test whether sex-specific delay discounting mediates the effects of alcohol on risky sexual decision making in MSM, using the CMM as a theoretical base for hypothesis testing
Participant Population
The participant population will consist of males age 21 to 35 years who are able to read and communicate in English. Eligible participants are: 1) single (i.e., not in a mutually monogamous relationship for at least 3 months); 2) sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months; and 3) have had condomless anal sex with a male partner in their lifetime; 4) have had at least one sexual encounter with a male partner met online in their lifetime; 5) characterized as a current heavy drinker, as defined by self-report of one or more episodes of heavy drinking (i.e., ≥5 standard drinks in a single occasion) during the past 30 days; and 5) HIV negative, based on self-report.
Non-drinkers, light to moderate drinkers, and individuals with current alcohol problems (as indexed by an AUDIT score ≥16) or drug problems (as indexed by a DAST score ≥6) will be excluded. Given that this is a study of MSM, females will be excluded. Furthermore, individuals who do not meet the relationship status and sexual activity criteria above will be excluded. Lastly, individuals who participated in Phase 1 of this research program will be excluded from Phase 2 Based on recruitment rates from studies at Brown, the investigators estimate that one quarter of participants completing the screening consent will be eligible for the study. As such, the investigators plan to obtain screening consent from approximately 600 to 800 individuals with the hope of yielding 150 to 180 participants eligible for the experimental session.
Recruitment and Screening
Participants will be recruited using established and approved methods that have been applied in our community, including online advertisement through the Brown CAAS and Brown Alcohol Research Center on HIV (ARCH) websites, flyers posted at CAAS- and ARCH-affiliated clinical and community centers, and flyers posted at public venues and organizations in the local community. In addition to these direct recruitment strategies, this study will employ chain referral sampling (i.e., "snowball sampling"), in which project staff will ask men who respond to our advertisements if they would be willing to inform others about our study.
Project staff will also contact individuals who have completed the online survey for our research participant pool. The participant pool survey provides an efficient means to identify individuals who are interested in participating in research studies on sexual minority men's health. The HRPP confirmed that the procedures necessary for creating and managing this participant pool do not constitute human subjects research, and therefore do not require IRB review. The participant pool survey includes items that are sufficient to determine whether an individual meets preliminary screening criteria for the current study. As with our other recruitment strategies, all individuals recruited through the participant pool will be asked to complete the dedicated screening consent and survey to determine full eligibility for this study.
Methodology and Procedures
Screening. Upon contact, potential participants will be given a brief description of the study and will receive a link to our online screening consent form and screening survey. Upon completion of the screening survey, those who do not meet the inclusion criteria will be notified of their ineligibility online. Eligible participants will be contacted by a research assistant to describe the experimental session further and confirm their interest in participating. Eligible participants will be informed that the experimental session will last 2.5 hours, plus the time it takes for BrAC to fall to .02%. Participants will be told not to drive to the session; public transportation or cab vouchers will be provided if necessary. Participants will be asked to bring photo identification to their session, to avoid using alcohol or drugs that are not prescribed (including over-the-counter drugs) for 24 hours prior to their appointments, and to fast for 3 hours before their appointments. Participants agreeing to these terms will be scheduled for the experimental session.
Informed Consent Procedure. All experimental sessions will be conducted at CAAS in Providence, RI. Our labs are designed to facilitate studies involving alcohol administration. When participants arrive to the lab, the research assistant will review photo identification to verify the participant's age, then they will collect a BrAC to ensure that they are .000%. Those with a BrAC above .000% will be rescheduled. Next, the research assistant will review all sections of the informed consent document with the participant. The research assistant will ask the participant if he understands the key component involved in participation, and will answer any remaining questions before obtaining the participant's signature on the appropriate documentation. After obtaining consent, the research assistant will review a standard medical condition agreement, which asks participants to indicate whether they have any medical conditions or are taking any medications for which alcohol use is contraindicated. RAs will emphasize that questions are being asked of participants to ensure their safety, and inquire about whether there are any safety reasons why they should not participate. Lists of affected conditions and medications will be provided.
Experimental Session Protocol. Participants will be randomly assigned to one of three potential conditions described above. The research assistant will collect measures of the participant's weight and height for determining the volume of beverage to be administered. This includes determining the appropriate dose of alcohol for those assigned to the alcohol condition. Dose amounts will be calculated using a well-validated algorithm. Next participants will be asked to complete a baseline assessment battery via computer-delivered self-report questionnaire. Finally, the research assistant will encourage the participant to use the restroom prior to initiating experimental procedures.
After completing the baseline measures, participants will undergo the beverage administration protocol, which will be identical for all participants so as to avoid bias due to potential timing effects. Duration and timing of beverage administration and post-drinking assessment is based on pharmacokinetic assumptions that peak blood alcohol is approximately 60 minutes after consumption. Participants in the alcohol condition will consume a volume of alcohol to reach a peak BrAC of .080g%. The total volume will be divided into three drinks to be consumed over the course of 15 minutes. Following consumption, BrAC will be measured every 5-minutes, and post-drinking assessment will be initiated when the participant's BrAC is .035g%, as this corresponds with the initiation of stimulant effects of alcohol. The estimated absorption period to reach this level is 10 to 20 minutes. Initiation of post-drink assessment for placebo and true control participants will be determined using a yoked control design, such that each control participant is assigned to undergo the same waiting period and the same number of breath tests as a corresponding alcohol participant.
Upon reaching a BrAC of .035g% (or comparable time for placebo and control), participants begin the post-drinking assessment protocol, comprising an arousal prime, two measures of sex-specific delay discounting, followed by the MSM stimulus story. The instructions for each of these tasks will be computer-delivered, and participant responses will be collected via computer-based self-report questionnaires. Within the MSM scenario, participants are asked in open-ended format to respond to other character in the story or to describe what happens next. These responses will be audio recorded using a digital recording device set to automatically record when the participant begins speaking. Throughout this protocol, which will last approximately 35-45 minutes, BrAC will be measured every 10-15 minutes for all participants independent of condition. To evaluate the success of the experimental manipulation, subjective intoxication (e.g., "how intoxicated do you feel?") will be measured every 10-15 minutes as well.
Following the assessment phase, participants in the placebo and control conditions will be debriefed and provided with a taxi home. Participants in the alcohol condition will begin the recovery period, in which they will be able to eat a snack, use the restroom, and wait comfortably. BrAC will be assessed every 15-20 minutes until it is verified at .02g% or below, at which point they will be debriefed and provided with a taxi or public transportation home.
- Conditions
- Binge Drinking, Unsafe Sex, HIV/AIDS, Sexually Transmitted Diseases
- Being tested
- Alcohol Administration, Placebo Alcohol Administration, No Alcohol Administration
- Keywords
- Alcohol, Delay Discounting, Risky Sexual Behavior, Decision Making, MSM
- Medical subject headings
- Binge Drinking, Unsafe Sex, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol AdministrationOther
In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence.
Placebo Alcohol AdministrationOther
In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims.
No Alcohol AdministrationOther
In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Experimental | In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. Receives: Other: Alcohol Administration |
| Placebo | Placebo comparator | In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. Receives: Other: Placebo Alcohol Administration |
| True Control | Sham comparator | In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. Receives: Other: No Alcohol Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Partner Delay Discounting Task
This delay discounting task measures hypothetical choice preference for immediately available sexual partners versus delayed but more attractive sexual partners. Data collected across 35 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate sexual activity.
Measured: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.
Sex Discounting Task
This discounting task measures the degree to which the value of hypothetical condom-protected sex decreases as a product of the amount of time one would have to wait for a condom to be available. Data collected across 32 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate and condomless sexual activity.
Measured: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.
Condomless Anal Sex Intentions
In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Intention to have condomless anal sex with this partner is assessed in the middle and at the end of this scenario. Intention is rates as "yes" or "no" in response to the question "In this situation, do you have anal sex with [this partner] without a condom?"
Measured: Approximately 45-50 minutes after beverage administration within our single-session, lab-based protocol.
Secondary outcomes (3)
Perceived Sex Potential
In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Perceives sex potential is assessed at the beginning of the scenario by asking "In this scenario, how likely are you to have sex tonight?" Participants respond using an 11-point scale with "0" anchored at "not at all likely" and "10" anchored at "very likely."
Measured: Approximately 35 minutes after beverage administration within our single-session, lab-based protocol.
Perceived Sexual Risks and Benefits Scale
In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Within the scenario, participants are asked "When thinking about whether or not to have sex with this partner tonight, would you consider each of the following reasons? Please mark YES if you would consider the reason, and NO if you would not consider it in this situation." The list comprises 34 items, including 17 perceived risks and 17 perceived benefits. For each risk and benefit endorsed, participants also rate the extent to which the reason would influence their decision using a 5-point scale, with "0" anchored at "not influential and "5" anchored at "extremely influential."
Measured: Approximately 40 minutes after beverage administration within our single-session, lab-based protocol.
Online Sexual Communication
In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. During the scenario, the participant is asked "At this point in the story, would you want to talk about anything else before agreeing to meet?" Participants who answer"yes" are then asked "What else you would want to talk about? Please use the text boxes below to describe what else you want to talk about." Responses are open ended. Finally, participants are asked "Each of the topics you want to discuss with this partner are listed below. For each, please write down exactly how you would ask this partner on Grindr. If you would use emoji in your message, please describe which ones?" Again, responses are open ended. These data are qualitative in nature.
Measured: Approximately 45 minutes after beverage administration within our single-session, lab-based protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 May 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Celio, Brown University
- Investigators
- Mark A Celio, PhD, Principal investigator, 1979
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224416
- Sponsor's protocol ID
- Project Now (Phase II)
- Status last verified
- Jul 2017
- First submitted
- 13 Mar 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Alcohol on Sex-Specific Delay Discounting and Subsequent Sexual Decision Making Among MSM
- ClinicalTrials.gov ID
- NCT03224416
- Acronym / sponsor ID
- Project Now (Phase II)
- Conditions
- Binge Drinking, Unsafe Sex, HIV/AIDS, Sexually Transmitted Diseases
- Keywords
- Alcohol, Delay Discounting, Risky Sexual Behavior, Decision Making, MSM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For decades, men who have sex with men (MSM) have carried the heaviest burden associated with the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately 4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV infections among males. Furthermore, the estimated number of new HIV infections attributed to male-to-male sexual contact is currently rising. In order to improve interventions to decrease transmission of HIV among MSM, it is important to have a better understanding of predictors of risky sexual behavior. Alcohol use is among the most reliable predictors of risky sexual behavior. Unfortunately, studies of alcohol use and risky sex among MSM have mainly relied on survey-based methods that cannot advance our understanding of the causal mechanisms linking acute alcohol use to HIV risk behavior.
This study will utilize an "alcohol/placebo/nonalcohol" design to examine the mechanisms underlying the association between the acute effects of alcohol (i.e., pharmacological and expectancy) and risky sexual decision making in MSM. Focal mechanisms include sex-specific delay discounting (SSDD), and the core constructs of the Cognitive Mediation Model. The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. This 3-group design will enable us to test the pharmacological effects of alcohol while accounting for potential expectancy effects. Participants (Target N = 150-180) will be randomly assigned to one condition; all will undergo the same protocol, which will be completed within one experimental session. The study protocol consists of baseline assessment, followed by beverage administration, followed by post-drinking assessment of SSDD and sexual decision making, followed by debriefing.
Detailed description
Significance and Specific Aims of Project
Men who have sex with men (MSM) continue to be disproportionately affected by the HIV epidemic in the United States. However, the experimental research designed to advance our knowledge of the causal link between alcohol use and risky sex has disproportionately focused on heterosexual men and women. Experimental studies are needed to test established theories and explore new mechanisms linking alcohol to HIV risk among MSM. This proposed project will experimentally test if sex-specific delay discounting (SSDD) is a mechanism of action underlying the association between alcohol and risky sexual behavior among MSM. More specifically stated, the aims are to:
- Examine the pharmacological effect of alcohol on sex-specific delay discounting in MSM, with the prediction that individuals who consume alcohol will display greater sexual impulsivity
- Examine the expectancy effect of alcohol on sex-specific delay discounting in MSM, with the prediction that those who receive placebo will evince greater sexual impulsivity than true controls
- Test whether sex-specific delay discounting mediates the effects of alcohol on risky sexual decision making in MSM, using the CMM as a theoretical base for hypothesis testing
Participant Population
The participant population will consist of males age 21 to 35 years who are able to read and communicate in English. Eligible participants are: 1) single (i.e., not in a mutually monogamous relationship for at least 3 months); 2) sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months; and 3) have had condomless anal sex with a male partner in their lifetime; 4) have had at least one sexual encounter with a male partner met online in their lifetime; 5) characterized as a current heavy drinker, as defined by self-report of one or more episodes of heavy drinking (i.e., ≥5 standard drinks in a single occasion) during the past 30 days; and 5) HIV negative, based on self-report.
Non-drinkers, light to moderate drinkers, and individuals with current alcohol problems (as indexed by an AUDIT score ≥16) or drug problems (as indexed by a DAST score ≥6) will be excluded. Given that this is a study of MSM, females will be excluded. Furthermore, individuals who do not meet the relationship status and sexual activity criteria above will be excluded. Lastly, individuals who participated in Phase 1 of this research program will be excluded from Phase 2 Based on recruitment rates from studies at Brown, the investigators estimate that one quarter of participants completing the screening consent will be eligible for the study. As such, the investigators plan to obtain screening consent from approximately 600 to 800 individuals with the hope of yielding 150 to 180 participants eligible for the experimental session.
Recruitment and Screening
Participants will be recruited using established and approved methods that have been applied in our community, including online advertisement through the Brown CAAS and Brown Alcohol Research Center on HIV (ARCH) websites, flyers posted at CAAS- and ARCH-affiliated clinical and community centers, and flyers posted at public venues and organizations in the local community. In addition to these direct recruitment strategies, this study will employ chain referral sampling (i.e., "snowball sampling"), in which project staff will ask men who respond to our advertisements if they would be willing to inform others about our study.
Project staff will also contact individuals who have completed the online survey for our research participant pool. The participant pool survey provides an efficient means to identify individuals who are interested in participating in research studies on sexual minority men's health. The HRPP confirmed that the procedures necessary for creating and managing this participant pool do not constitute human subjects research, and therefore do not require IRB review. The participant pool survey includes items that are sufficient to determine whether an individual meets preliminary screening criteria for the current study. As with our other recruitment strategies, all individuals recruited through the participant pool will be asked to complete the dedicated screening consent and survey to determine full eligibility for this study.
Methodology and Procedures
Screening. Upon contact, potential participants will be given a brief description of the study and will receive a link to our online screening consent form and screening survey. Upon completion of the screening survey, those who do not meet the inclusion criteria will be notified of their ineligibility online. Eligible participants will be contacted by a research assistant to describe the experimental session further and confirm their interest in participating. Eligible participants will be informed that the experimental session will last 2.5 hours, plus the time it takes for BrAC to fall to .02%. Participants will be told not to drive to the session; public transportation or cab vouchers will be provided if necessary. Participants will be asked to bring photo identification to their session, to avoid using alcohol or drugs that are not prescribed (including over-the-counter drugs) for 24 hours prior to their appointments, and to fast for 3 hours before their appointments. Participants agreeing to these terms will be scheduled for the experimental session.
Informed Consent Procedure. All experimental sessions will be conducted at CAAS in Providence, RI. Our labs are designed to facilitate studies involving alcohol administration. When participants arrive to the lab, the research assistant will review photo identification to verify the participant's age, then they will collect a BrAC to ensure that they are .000%. Those with a BrAC above .000% will be rescheduled. Next, the research assistant will review all sections of the informed consent document with the participant. The research assistant will ask the participant if he understands the key component involved in participation, and will answer any remaining questions before obtaining the participant's signature on the appropriate documentation. After obtaining consent, the research assistant will review a standard medical condition agreement, which asks participants to indicate whether they have any medical conditions or are taking any medications for which alcohol use is contraindicated. RAs will emphasize that questions are being asked of participants to ensure their safety, and inquire about whether there are any safety reasons why they should not participate. Lists of affected conditions and medications will be provided.
Experimental Session Protocol. Participants will be randomly assigned to one of three potential conditions described above. The research assistant will collect measures of the participant's weight and height for determining the volume of beverage to be administered. This includes determining the appropriate dose of alcohol for those assigned to the alcohol condition. Dose amounts will be calculated using a well-validated algorithm. Next participants will be asked to complete a baseline assessment battery via computer-delivered self-report questionnaire. Finally, the research assistant will encourage the participant to use the restroom prior to initiating experimental procedures.
After completing the baseline measures, participants will undergo the beverage administration protocol, which will be identical for all participants so as to avoid bias due to potential timing effects. Duration and timing of beverage administration and post-drinking assessment is based on pharmacokinetic assumptions that peak blood alcohol is approximately 60 minutes after consumption. Participants in the alcohol condition will consume a volume of alcohol to reach a peak BrAC of .080g%. The total volume will be divided into three drinks to be consumed over the course of 15 minutes. Following consumption, BrAC will be measured every 5-minutes, and post-drinking assessment will be initiated when the participant's BrAC is .035g%, as this corresponds with the initiation of stimulant effects of alcohol. The estimated absorption period to reach this level is 10 to 20 minutes. Initiation of post-drink assessment for placebo and true control participants will be determined using a yoked control design, such that each control participant is assigned to undergo the same waiting period and the same number of breath tests as a corresponding alcohol participant.
Upon reaching a BrAC of .035g% (or comparable time for placebo and control), participants begin the post-drinking assessment protocol, comprising an arousal prime, two measures of sex-specific delay discounting, followed by the MSM stimulus story. The instructions for each of these tasks will be computer-delivered, and participant responses will be collected via computer-based self-report questionnaires. Within the MSM scenario, participants are asked in open-ended format to respond to other character in the story or to describe what happens next. These responses will be audio recorded using a digital recording device set to automatically record when the participant begins speaking. Throughout this protocol, which will last approximately 35-45 minutes, BrAC will be measured every 10-15 minutes for all participants independent of condition. To evaluate the success of the experimental manipulation, subjective intoxication (e.g., "how intoxicated do you feel?") will be measured every 10-15 minutes as well.
Following the assessment phase, participants in the placebo and control conditions will be debriefed and provided with a taxi home. Participants in the alcohol condition will begin the recovery period, in which they will be able to eat a snack, use the restroom, and wait comfortably. BrAC will be assessed every 15-20 minutes until it is verified at .02g% or below, at which point they will be debriefed and provided with a taxi or public transportation home.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Experimental | Other: Alcohol AdministrationIn the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. |
| Placebo | Placebo comparator | Other: Placebo Alcohol AdministrationIn the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. |
| True Control | Sham comparator | Other: No Alcohol AdministrationIn the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- single (i.e., not in a mutually monogamous relationship for at least 3 months)
- sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months
- have had condomless anal sex with a male partner in their lifetime
- have had at least one sexual encounter with a male partner met online in their lifetime
- characterized as a current heavy drinker, as defined by self-report of one or more episodes of heavy drinking (i.e., ≥5 standard drinks in a single occasion) during the past 30 days; and 5) HIV negative, based on self-report.
Key exclusion criteria (4 listed)
- Non-drinkers and light to moderate drinkers
- Individuals with current alcohol problems (as indexed by an AUDIT score ≥16)
- Individuals with current drug problems (as indexed by a DAST score ≥6)
- Females (as this is a study of men who have sex with men).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol AdministrationIn the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. | Other | Alcohol |
| Placebo Alcohol AdministrationIn the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. | Other | Placebo |
| No Alcohol AdministrationIn the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. | Other | True Control |
Primary outcome
Sexual Partner Delay Discounting Task
Time frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.
This delay discounting task measures hypothetical choice preference for immediately available sexual partners versus delayed but more attractive sexual partners. Data collected across 35 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate sexual activity.
Sex Discounting Task
Time frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.
This discounting task measures the degree to which the value of hypothetical condom-protected sex decreases as a product of the amount of time one would have to wait for a condom to be available. Data collected across 32 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate and condomless sexual activity.
Condomless Anal Sex Intentions
Time frame: Approximately 45-50 minutes after beverage administration within our single-session, lab-based protocol.
In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Intention to have condomless anal sex with this partner is assessed in the middle and at the end of this scenario. Intention is rates as "yes" or "no" in response to the question "In this situation, do you have anal sex with [this partner] without a condom?"
3 secondary outcomes
Perceived Sex Potential
Time frame: Approximately 35 minutes after beverage administration within our single-session, lab-based protocol.
Perceived Sexual Risks and Benefits Scale
Time frame: Approximately 40 minutes after beverage administration within our single-session, lab-based protocol.
Online Sexual Communication
Time frame: Approximately 45 minutes after beverage administration within our single-session, lab-based protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Celio, PhD principal investigator
1979
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Administration and No Alcohol Administration in people with Binge Drinking and Unsafe Sex, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark A Celio, PhD (401-863-6662, mark_celio@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Partner Delay Discounting Task (time frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.