Heavy DrinkingNCT05090995
A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults
A study testing Behavioral Self-Management and Feedback and Behavioral Self-Management in people with Heavy Drinking and Harmful; Use, Alcohol, run by Yale University at 1 site in United States.
Trial summary
Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking, Harmful; Use, Alcohol
- What is being tested?
- Behavioral Self-Management and Feedback and Behavioral Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-25 years of age
- Report ≥ 4 heavy drinking occasions in the past 28 days
- Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm
- English Speaking
- Have a personal smartphone
Who cannot join
- Sleep Disorder History
- Night/ Rotating work shift
- Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation
- Clinically severe AUD in past 12 months
- Currently enrolled in alcohol or sleep treatment
- Current, severe psychiatric illness
- Current DSM-V substance use disorder
- Positive urine drug screen for a substance other than marijuana
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep
Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.
Read the detailed description
Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.
- Conditions
- Heavy Drinking, Harmful; Use, Alcohol
- Being tested
- Behavioral Self-Management and Feedback, Behavioral Self-Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Self-Management and FeedbackBehavioural
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice.
Behavioral Self-ManagementBehavioural
Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries.
| Study group | Role | What they receive |
|---|---|---|
| Self-Monitoring and Feedback | Active comparator | The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries. Receives: Behavioral: Behavioral Self-Management and Feedback |
| Self-Monitoring | Placebo comparator | The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. Receives: Behavioral: Behavioral Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Drinks Consumed
Total drinks consumed will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many drinks they consume each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater number of drinks consumed. Total drinks will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks over time with condition, time, and their interaction in the model and sex and baseline total drinks as covariates.
Measured: up to Week 10
Secondary outcomes (9)
Drinks Per Drinking Day
Total drinks per drinking day will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. Total drinks/drinking day will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks/drinking day over time with condition, time, and their interaction in the model and sex and baseline drinks per drinking day as covariates.
This tools asks subjects to self-report how many drinks they consume during a one month period. The score of this measure will be determined by the amount of self-reported alcohol consumption that occurred each day. A heavy drinking day for a man would be ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting.
Measured: up to 10 weeks
Percent Heavy Drinking Days
Self-reported percent heavy drinking days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report heavy drinking occasions over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10, defined as ≥5 drinks per sitting and for a women it would be ≥4 drinks per sitting. Higher scores indicate a greater percentage of heavy drinking days. The percentage of heavy drinking days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent heavy drinking days over time with condition, time, and their interaction in the model and sex and baseline percent heavy drinking days as covariates.
Measured: up to 10 weeks
Percent Abstinent Days
Self-reported percent abstinent days will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many days they did not consume any alcohol each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater percentage of abstinent days. The percentage of abstinent days will be summed over the past 4 weeks at intake, Week 6, and Week 10. Mixed effects models were then conducted to evaluate the effect of condition on percent abstinent days over time with condition, time, and their interaction in the model and sex and baseline percent abstinent days as covariates.
Measured: up to 10 weeks
Alcohol-related Consequences
Mean alcohol related consequences were measured using the Brief Young Adult Alcohol Consequences Questionnaire at baseline, Week 6, and Week 10. Each consequence is scored 1 point and a total score reflects the total number of consequences. Higher scores indicated more consequences.Total score range 0-24. The three timepoints are summed then averaged. Mixed effects models were then conducted to evaluate the effect of condition on consequences over time with condition, time, and their interaction in the model and sex and baseline consequences as covariates.
Measured: baseline, Week 6, and Week 10
Sleep Quality
Mean sleep quality will be measured using the PROMIS - Sleep Disturbance Form 8 assessment. The sleep disturbance assessment has 8 questions that yield a total score (summed scores). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences worse sleep quality. Mixed effects models were then conducted to evaluate the effect of condition on sleep quality over time with condition, time, and their interaction in the model and sex and baseline sleep quality as covariates.
Measured: baseline and Week 10
Sleep-related Impairment
Mean sleep quality will be measured using the PROMIS - Sleep-Related Impairment Form 8 assessment. The sleep impairment assessment has 8 questions that yield a total score (summed score). This raw score is then converted to a standardized T score from 0-100 with a mean score of 50. A score above the mean would indicate that the subject experiences more sleep-related impairment. Mixed effects models were then conducted to evaluate the effect of condition on sleep-related impairment over time with condition, time, and their interaction in the model and sex and baseline sleep-related impairment as covariates.
Measured: baseline and Week 10
Sleep Duration
Mean sleep duration will be measured daily for 6 weeks by the PPG device. Sleep duration will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a square-root transformation.
Measured: up to 6 weeks
Heart Rate Variability (HRV)
Heart rate variability (HRV) will be measured daily for 6 weeks by the PPG device. HRV will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation.
Measured: up to 6 weeks
Lowest Resting Heart Rate (RHR)
Lowest Resting Heart Rate (RHR) will be measured daily for 6 weeks by the PPG device. The lowest value will then be averaged in 2-week intervals at Weeks 2, 4, and 6 and evaluated over time using mixed effects models with condition, time, and their interaction in the model and sex and an indicator variable of weekday vs. weekend as covariates. Sleep duration was transformed using a log transformation. RHR can vary anywhere between 40-100 beats per minute. Lower RHR would indicate better cardiovascular health.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start23 Feb 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (78)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- More trials run by Yale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized into either the Assessment or Feedback group. Subjects in the assessment group will not receive personalized health feedback or advice on their health behaviors. They will wear a consumer- level PPG device daily and complete electronic diaries about bedtime behavior and sleep from the previous night for six weeks. Subjects in the feedback group will also wear a consumer-level PPG device and complete diaries each morning for six weeks. Subjects in this group will monitor their health behaviors and receive personalized feedback and advice. Subjects will also be able to receive daily information regarding their health behaviors from the PPG device application. At weeks two, four, and six subjects will will receive written reports that summarize their alcohol usage and the links made between their drinking and health outcomes from the PPG application results. Subjects will also receive advice on how to improve health behaviors.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Lisa Fucito, PhD, Principal investigator, Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090995
- Sponsor's protocol ID
- 2000030417
- Other IDs
- 1R21AA028886-01A1, 21-002981
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2021
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falk D, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol and drug use and disorders: findings from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC). Alcohol Res Health. 2008;31(2):100-10.
PubMed 23584812Administration, S.A.a.M.H.S. Key substance use and mental health indicators in the United States: Results from the National Survey on Drug Use and Health, Center for Behavioral Health Statistics and Quality. 2019; Available from: https://www.samhsa.gov/data/.
Hingson RW, Zha W, Weitzman ER. Magnitude of and trends in alcohol-related mortality and morbidity among U.S. college students ages 18-24, 1998-2005. J Stud Alcohol Drugs Suppl. 2009 Jul;(16):12-20. doi: 10.15288/jsads.2009.s16.12.
PubMed 19538908NIAAA, Alcohol involvement over the life course, E. U. S. Department of Health and Human Services, Editor. 2000 Bethesda, MD. p. p. 28-53.
NIAAA, Alcohol and Other Drugs. Alcohol Alert, 2008. 76.
Cronce JM, Larimer ME. Individual-focused approaches to the prevention of college student drinking. Alcohol Res Health. 2011;34(2):210-21.
PubMed 22330220Carey KB, Scott-Sheldon LA, Carey MP, DeMartini KS. Individual-level interventions to reduce college student drinking: a meta-analytic review. Addict Behav. 2007 Nov;32(11):2469-94. doi: 10.1016/j.addbeh.2007.05.004. Epub 2007 May 17.
PubMed 17590277Carey KB, Scott-Sheldon LA, Elliott JC, Bolles JR, Carey MP. Computer-delivered interventions to reduce college student drinking: a meta-analysis. Addiction. 2009 Nov;104(11):1807-19. doi: 10.1111/j.1360-0443.2009.02691.x. Epub 2009 Sep 10.
PubMed 19744139Buscemi J, Murphy JG, Martens MP, McDevitt-Murphy ME, Dennhardt AA, Skidmore JR. Help-seeking for alcohol-related problems in college students: correlates and preferred resources. Psychol Addict Behav. 2010 Dec;24(4):571-80. doi: 10.1037/a0021122.
PubMed 21198220Black DR, Coster DC. Interest in a stepped approach model (SAM): identification of recruitment strategies for university alcohol programs. Health Educ Q. 1996 Feb;23(1):98-114. doi: 10.1177/109019819602300107.
PubMed 8822404Wu LT, Pilowsky DJ, Schlenger WE, Hasin D. Alcohol use disorders and the use of treatment services among college-age young adults. Psychiatr Serv. 2007 Feb;58(2):192-200. doi: 10.1176/ps.2007.58.2.192.
PubMed 17287375Caldeira KM, Kasperski SJ, Sharma E, Vincent KB, O'Grady KE, Wish ED, Arria AM. College students rarely seek help despite serious substance use problems. J Subst Abuse Treat. 2009 Dec;37(4):368-78. doi: 10.1016/j.jsat.2009.04.005. Epub 2009 Jun 23.
PubMed 19553064Fortuna RJ, Robbins BW, Halterman JS. Ambulatory care among young adults in the United States. Ann Intern Med. 2009 Sep 15;151(6):379-85. doi: 10.7326/0003-4819-151-6-200909150-00002.
PubMed 19755363O'hara, B. and K. Caswell, Health status, health insurance, and medical services utilization: 2010. Curr Pop Rep, 2012. 2012: p. 70-133.
Kaner EF, Beyer FR, Muirhead C, Campbell F, Pienaar ED, Bertholet N, Daeppen JB, Saunders JB, Burnand B. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev. 2018 Feb 24;2(2):CD004148. doi: 10.1002/14651858.CD004148.pub4.
PubMed 29476653
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep
- ClinicalTrials.gov ID
- NCT05090995
- Acronym / sponsor ID
- 2000030417
- Conditions
- Heavy Drinking, Harmful; Use, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.
Detailed description
Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomized into either the Assessment or Feedback group. Subjects in the assessment group will not receive personalized health feedback or advice on their health behaviors. They will wear a consumer- level PPG device daily and complete electronic diaries about bedtime behavior and sleep from the previous night for six weeks. Subjects in the feedback group will also wear a consumer-level PPG device and complete diaries each morning for six weeks. Subjects in this group will monitor their health behaviors and receive personalized feedback and advice. Subjects will also be able to receive daily information regarding their health behaviors from the PPG device application. At weeks two, four, and six subjects will will receive written reports that summarize their alcohol usage and the links made between their drinking and health outcomes from the PPG application results. Subjects will also receive advice on how to improve health behaviors.
| Arm | Type | Receives |
|---|---|---|
| Self-Monitoring and Feedback | Active comparator | Behavioral: Behavioral Self-Management and FeedbackThe intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries. |
| Self-Monitoring | Placebo comparator | Behavioral: Behavioral Self-ManagementThe intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-25 years of age
- Report ≥ 4 heavy drinking occasions in the past 28 days
- Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm
- English Speaking
- Have a personal smartphone
Key exclusion criteria (8 listed)
- Sleep Disorder History
- Night/ Rotating work shift
- Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation
- Clinically severe AUD in past 12 months
- Currently enrolled in alcohol or sleep treatment
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 |
|---|---|---|
| Behavioral Self-Management and FeedbackSelf-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice. | Behavioural | Self-Monitoring and Feedback |
| Behavioral Self-ManagementSelf-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries. | Behavioural | Self-Monitoring |
Primary outcome
Total Drinks Consumed
Time frame: up to Week 10
Total drinks consumed will be measured using the Time Line Followback Interview at baseline, Week 6, and Week 10. This standardized interview asks subjects to self-report how many drinks they consume each day over the past 4 weeks at baseline and then since the last assessment point at Weeks 6 and 10. Higher scores indicate a greater number of drinks consumed. Total drinks will be summed over the past 4 weeks at intake, Week 6, and Week 10. Totals were transformed using a square root transformation since these values were not normally distributed. Mixed effects models were then conducted to evaluate the effect of condition on total drinks over time with condition, time, and their interaction in the model and sex and baseline total drinks as covariates.
9 secondary outcomes
Drinks Per Drinking Day
Time frame: up to 10 weeks
Percent Heavy Drinking Days
Time frame: up to 10 weeks
Percent Abstinent Days
Time frame: up to 10 weeks
Alcohol-related Consequences
Time frame: baseline, Week 6, and Week 10
Sleep Quality
Time frame: baseline and Week 10
Sleep-related Impairment
Time frame: baseline and Week 10
Sleep Duration
Time frame: up to 6 weeks
Heart Rate Variability (HRV)
Time frame: up to 6 weeks
Lowest Resting Heart Rate (RHR)
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23584812Falk D, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol and drug use and disorders: findings from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC). Alcohol Res Health. 2008;31(2):100-10.
- BackgroundAdministration, S.A.a.M.H.S. Key substance use and mental health indicators in the United States: Results from the National Survey on Drug Use and Health, Center for Behavioral Health Statistics and Quality. 2019; Available from: https://www.samhsa.gov/data/.
- Background: PubMed 19538908Hingson RW, Zha W, Weitzman ER. Magnitude of and trends in alcohol-related mortality and morbidity among U.S. college students ages 18-24, 1998-2005. J Stud Alcohol Drugs Suppl. 2009 Jul;(16):12-20. doi: 10.15288/jsads.2009.s16.12.
- BackgroundNIAAA, Alcohol involvement over the life course, E. U. S. Department of Health and Human Services, Editor. 2000 Bethesda, MD. p. p. 28-53.
- BackgroundNIAAA, Alcohol and Other Drugs. Alcohol Alert, 2008. 76.
- Background: PubMed 22330220Cronce JM, Larimer ME. Individual-focused approaches to the prevention of college student drinking. Alcohol Res Health. 2011;34(2):210-21.
- Background: PubMed 17590277Carey KB, Scott-Sheldon LA, Carey MP, DeMartini KS. Individual-level interventions to reduce college student drinking: a meta-analytic review. Addict Behav. 2007 Nov;32(11):2469-94. doi: 10.1016/j.addbeh.2007.05.004. Epub 2007 May 17.
- Background: PubMed 19744139Carey KB, Scott-Sheldon LA, Elliott JC, Bolles JR, Carey MP. Computer-delivered interventions to reduce college student drinking: a meta-analysis. Addiction. 2009 Nov;104(11):1807-19. doi: 10.1111/j.1360-0443.2009.02691.x. Epub 2009 Sep 10.
- Background: PubMed 21198220Buscemi J, Murphy JG, Martens MP, McDevitt-Murphy ME, Dennhardt AA, Skidmore JR. Help-seeking for alcohol-related problems in college students: correlates and preferred resources. Psychol Addict Behav. 2010 Dec;24(4):571-80. doi: 10.1037/a0021122.
- Background: PubMed 8822404Black DR, Coster DC. Interest in a stepped approach model (SAM): identification of recruitment strategies for university alcohol programs. Health Educ Q. 1996 Feb;23(1):98-114. doi: 10.1177/109019819602300107.
- Background: PubMed 17287375Wu LT, Pilowsky DJ, Schlenger WE, Hasin D. Alcohol use disorders and the use of treatment services among college-age young adults. Psychiatr Serv. 2007 Feb;58(2):192-200. doi: 10.1176/ps.2007.58.2.192.
- Background: PubMed 19553064Caldeira KM, Kasperski SJ, Sharma E, Vincent KB, O'Grady KE, Wish ED, Arria AM. College students rarely seek help despite serious substance use problems. J Subst Abuse Treat. 2009 Dec;37(4):368-78. doi: 10.1016/j.jsat.2009.04.005. Epub 2009 Jun 23.
- 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.
Lisa Fucito, PhD principal investigator
Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Self-Management and Feedback and Behavioral Self-Management in people with Heavy Drinking and Harmful; Use, Alcohol, run by Yale 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 8 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: finished, as of the sponsor's last update on 13 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Drinks Consumed (time frame: up to Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090995, which also lists 78 linked publications.
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 13 Dec 2024.