Alcohol AbusePhase 1NCT03165942
Neuroendocrine Response to Oral Alcohol Administration
A Phase 1 study testing Alcoholic Beverage, Non-Alcoholic Beverage and Ethanol in people with Alcohol Abuse, run by Yale University at 1 site in United States.
Trial summary
This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to oral ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Alcoholic Beverage, Non-Alcoholic Beverage and Ethanol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2016to 30 Jun 2018
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Binge/Heavy Social Drinkers (HSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of at least 10 drinks per week, including at lease one occasion per week consuming >4 drinks (males) or >3 drinks (females).
- Able to read and write English.
- Light Social Drinkers (LSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of 1-3 drinks per occasion, 1-3 times weekly, with no more than one occasion per month of drinking >4 drinks (male) or >3 drinks (females) (King et al., 2002).
- Do not meet criteria for any Axis I DSM-IV psychiatric diagnoses except for individuals with a past diagnosis of Post-Traumatic Stress Disorder, Major Depressive Disorder, or Obsessive Compulsive Disorder; and provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
- Body Mass Index between 20-28.
- No current or former nicotine dependence.
Who cannot join
- Meet current criteria for dependence on any psychoactive substance, excluding caffeine.
- Current or past history of alcohol dependence or abuse.
- Any current use of opiates or past history of opiate abuse/dependence.
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
- Peri and post menopausal women, and those with hysterectomies.
- Pregnant and lactating women will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to oral ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the association between stress, cortisol release, heart rate variability, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.
Read the detailed description
This study was a single-blind, mixed Between Subjects and repeated measures across Alcohol and Placebo conditions in separate sessions in a 2 scan neuroimaging experiment. The two groups of participants were Moderate Social Drinkers and Binge/Heavy Social Drinkers, categorized on the basis of NIAA criteria for moderate non-binge and binge/heavy drinking. Subjects were randomly assigned to receive alcoholic or non-alcoholic beer in scanning condition 1 or condition 2. Before each scan, they were exposed to 3 12 Oz. alcoholic beer or 3 12 Oz. non-alcoholic beer via an Alcohol Taste Test (ATT) during which they were asked to taste the beers to determine if they were same or different. The order of the two conditions was counterbalanced and randomized across participants. Cerebral blood flow (CBF) was then measured using Arterial Spin Labeling. In addition to measuring the different effects of alcoholic beer vs. non-alcoholic beer on CBF, the investigators also measured subjective alcohol effects, alcohol craving, breath alcohol levels, cortisol, and ACTH. Statistical tests were performed to determine if these dependent measures were due to Group, Condition, or a Group x Condition interaction. Finally, the relationship between these variables and the amount of beer consumed at the second post-scan ATT was examined. The post-scan ATT only presented with the choice to drink non-alcoholic beer in order to more clearly predict behavioral motivation for alcohol from PreATT alcohol response in cortisol, CBF and subjective ratings. Data was obtained by research staff, nurse, and MRI technician who were blind to condition as were the subjects but PI and project director were not blind.
- Conditions
- Alcohol Abuse
- Being tested
- Alcoholic Beverage, Non-Alcoholic Beverage, Ethanol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcoholic BeverageOther
In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
Non-Alcoholic BeverageOther
In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
EthanolDrug
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic Beverage | Experimental | Participants will complete an MRI and oral alcohol session. Receives: Other: Alcoholic Beverage; Drug: Ethanol |
| Non-Alcoholic Beverage | Placebo comparator | Participants will complete an MRI and oral non-alcoholic session. Receives: Other: Non-Alcoholic Beverage; Drug: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Flow
Blood flow is measured in ml/100 grams/minute. The interpretation is that blood flow to that area indicates that region of the brain is responding to the consumption of alcohol or alcohol cues. Change in blood flow will be calculated as the change (and slope) of measurements taken at 10, 20, 30 and 45 minutes during the procedure.
Measured: End of Procedure (45 minutes)
Change in Amount of drink consumed (alcohol or placebo)
Amount of drink consumed (alcohol or placebo) during the Alcohol Taste Test (ATT)
Measured: Pre-scan ATT and immediately Post scan ATT
Secondary outcomes (4)
Changes in Alcohol Effects (BAES)
Alcohol effects will be measured using the Biphasic Alcohol Effects Scale (BAES). The BAES is a 12 item questionnaire with a 12-120 range. The higher the total value (up to 120), the greater the measured effects of alcohol. The change in alcohol effects will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.
Measured: Post follow up to Procedure (125 minutes)
Changes in Alcohol Effects (DEQ)
Alcohol effects will be measured using the Drug Effects Questionnaire (DEQ). The DEQ consists of 5 questions with 5-25 total point distribution. The greater the total points, the greater the measured effect of alcohol. The change in alcohol effects will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.
Measured: Post follow up to Procedure (125 minutes)
Changes in Alcohol Urges (AUQ)
The urge to consume alcohol will be measured using the Alcohol Urge Questionnaire (AUQ). The AUQ consists of 8 questions 8-56 total point distribution. The greater the total points, the greater the measured urge to consume alcohol. The change in alcohol urge will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.
Measured: Post follow up to Procedure (125 minutes)
Change in Cortisol
The units for cortisol are micrograms/deciliter and the interpretation is that amount has been released into the blood stream from the HPA axis in response to alcohol or alcohol cues. Change in Cortisol will be calculated by taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.
Measured: Post follow up to Procedure (125 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start8 Sep 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 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
- Sara Blaine, PhD, Principal investigator, Addictions, Division of Yale Stress CenterRajita Sinha, PhD, Principal investigator, Professor of Psychiatry, Yale Center for Clinical Investigation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165942
- Sponsor's protocol ID
- 1502015387
- Other IDs
- 1R21AA025277-01, 1K99AA025401-01A1
- Status last verified
- Aug 2022
- First submitted
- 19 May 2017
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Response to Oral Alcohol Administration
- ClinicalTrials.gov ID
- NCT03165942
- Acronym / sponsor ID
- 1502015387
- Conditions
- Alcohol Abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 24 May 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.
This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to oral ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the association between stress, cortisol release, heart rate variability, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.
Detailed description
This study was a single-blind, mixed Between Subjects and repeated measures across Alcohol and Placebo conditions in separate sessions in a 2 scan neuroimaging experiment. The two groups of participants were Moderate Social Drinkers and Binge/Heavy Social Drinkers, categorized on the basis of NIAA criteria for moderate non-binge and binge/heavy drinking. Subjects were randomly assigned to receive alcoholic or non-alcoholic beer in scanning condition 1 or condition 2. Before each scan, they were exposed to 3 12 Oz. alcoholic beer or 3 12 Oz. non-alcoholic beer via an Alcohol Taste Test (ATT) during which they were asked to taste the beers to determine if they were same or different. The order of the two conditions was counterbalanced and randomized across participants. Cerebral blood flow (CBF) was then measured using Arterial Spin Labeling. In addition to measuring the different effects of alcoholic beer vs. non-alcoholic beer on CBF, the investigators also measured subjective alcohol effects, alcohol craving, breath alcohol levels, cortisol, and ACTH. Statistical tests were performed to determine if these dependent measures were due to Group, Condition, or a Group x Condition interaction. Finally, the relationship between these variables and the amount of beer consumed at the second post-scan ATT was examined. The post-scan ATT only presented with the choice to drink non-alcoholic beer in order to more clearly predict behavioral motivation for alcohol from PreATT alcohol response in cortisol, CBF and subjective ratings. Data was obtained by research staff, nurse, and MRI technician who were blind to condition as were the subjects but PI and project director were not blind.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic Beverage | Experimental | Other: Alcoholic Beverage, Drug: EthanolParticipants will complete an MRI and oral alcohol session. |
| Non-Alcoholic Beverage | Placebo comparator | Other: Non-Alcoholic Beverage, Drug: EthanolParticipants will complete an MRI and oral non-alcoholic session. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Binge/Heavy Social Drinkers (HSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of at least 10 drinks per week, including at lease one occasion per week consuming >4 drinks (males) or >3 drinks (females).
- Able to read and write English.
- Light Social Drinkers (LSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of 1-3 drinks per occasion, 1-3 times weekly, with no more than one occasion per month of drinking >4 drinks (male) or >3 drinks (females) (King et al., 2002).
- Do not meet criteria for any Axis I DSM-IV psychiatric diagnoses except for individuals with a past diagnosis of Post-Traumatic Stress Disorder, Major Depressive Disorder, or Obsessive Compulsive Disorder; and provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
- Body Mass Index between 20-28.
Key exclusion criteria (8 listed)
- Meet current criteria for dependence on any psychoactive substance, excluding caffeine.
- Current or past history of alcohol dependence or abuse.
- Any current use of opiates or past history of opiate abuse/dependence.
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
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 |
|---|---|---|
| Alcoholic BeverageIn addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session. | Other | Alcoholic Beverage |
| Non-Alcoholic BeverageIn addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session. | Other | Non-Alcoholic Beverage |
| Ethanol | Drug | Alcoholic Beverage, Non-Alcoholic Beverage |
Primary outcome
Change in Blood Flow
Time frame: End of Procedure (45 minutes)
Blood flow is measured in ml/100 grams/minute. The interpretation is that blood flow to that area indicates that region of the brain is responding to the consumption of alcohol or alcohol cues. Change in blood flow will be calculated as the change (and slope) of measurements taken at 10, 20, 30 and 45 minutes during the procedure.
Change in Amount of drink consumed (alcohol or placebo)
Time frame: Pre-scan ATT and immediately Post scan ATT
Amount of drink consumed (alcohol or placebo) during the Alcohol Taste Test (ATT)
4 secondary outcomes
Changes in Alcohol Effects (BAES)
Time frame: Post follow up to Procedure (125 minutes)
Changes in Alcohol Effects (DEQ)
Time frame: Post follow up to Procedure (125 minutes)
Changes in Alcohol Urges (AUQ)
Time frame: Post follow up to Procedure (125 minutes)
Change in Cortisol
Time frame: Post follow up to Procedure (125 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sara Blaine, PhD principal investigator
Addictions, Division of Yale Stress Center
Rajita Sinha, PhD principal investigator
Professor of Psychiatry, Yale Center for Clinical Investigation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alcoholic Beverage, Non-Alcoholic Beverage and Ethanol in people with Alcohol Abuse, 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 6 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 4 Aug 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Blood Flow (time frame: End of Procedure (45 minutes)). The study lists 2 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 4 Aug 2022.