Binge DrinkingNCT03928626
Brief ROC Training Effects on Alcohol Drinking
A study testing Regulation of craving in people with Binge Drinking and Heavy Drinking, run by Yale University at 1 site in United States.
Trial summary
The goal of the proposed study is to examine whether a single session of training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of (1) a basic screening (phone and/or online) and an in-person visit, to determine eligibility and conduct pre-intervention baseline assessments; (2) a… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking, Heavy Drinking, Young Adult
- What is being tested?
- Regulation of craving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 15 Mar 2020
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ages 18-25
- Capability of performing the experimental tasks (e.g., can read, able to use computers)
- Native or fluent speaker of English
- Provides informed consent
- Normal or corrected-to-normal vision
- Willing to commit to the full length of the protocol
- Heavy drinking or binge-drinking
Who cannot join
- Present DSM disorders, apart from alcohol use disorders
- Reports of neurological or systemic disorders that can cause cognitive impairment
- Minor cognitive impairment evidenced by an inability to correctly understand study information
- Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation Ladder score of 9 or 10).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical & Affective Neuroscience Lab
New Haven, Connecticut, 06510
About this study
The goal of the proposed study is to examine whether a single session of training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of (1) a basic screening (phone and/or online) and an in-person visit, to determine eligibility and conduct pre-intervention baseline assessments; (2) a training (ROC-T) visit, (3) a post-intervention assessment visit, and (4) 1-2 phone/online follow-up assessments.
The study will take up to 10 hours of the participants' time.
Read the detailed description
The investigators propose to test the efficacy of such training by randomizing 120 individuals who report alcohol drinking to the following conditions: (1) a brief training in cognitive regulation and (2) a control or no-training condition. Training will be delivered in a computerized session (approximately 60 minutes). If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy while viewing images of alcoholic drinks. The strategy would be to follow instructions to think about the adverse outcomes associated with continued alcohol drinking. If randomized into the control condition, participants will only view non-alcohol-related images with no use of strategy. After all the training sessions are completed, participants will complete several follow-ups. The investigators will evaluate the effects of training on alcohol drinking pre- and post-training.
- Conditions
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Alcohol Drinking, Alcohol Drinking in College
- Being tested
- Regulation of craving, Control (NO REGULATION)
- Keywords
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of craving, Cognitive behavioral therapy, Neurocognitive training, Emotion regulation, Alcohol
- Medical subject headings
- Binge Drinking, Alcoholic Intoxication, Alcohol Drinking, Alcohol Drinking in College, Drinking Behavior, Alcoholism, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulation of cravingBehavioural
Also called Neurocognitive training
Participants in the ROC-T condition will be trained to use a strategy that instructs them to think of the negative outcomes associated with alcohol drinking while looking at alcohol-related images.
Control (NO REGULATION)Behavioural
Also called Sham (No regulation)
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
| Study group | Role | What they receive |
|---|---|---|
| CRAVING REGULATION | Active comparator | In the CRAVING REGULATION condition, participants will first read a brief essay about the adverse consequences of drinking alcohol. Then, participants may complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will be trained to use the information to inform the strategy they will use in the regulation of craving training (ROC-T). A single trial in the regulation of craving training will have two possible instructions: (a) STRATEGY: implement the strategy ("bring to mind the negative facts from the essay") and (b) LOOK: to merely observe the image and allow natural responses to come. Participants will follow the instructions; followed by an alcohol-related picture, a brief delay, and will then rate their craving. Participants will then be instructed to use this strategy in daily life situations when they might drink. Receives: Behavioral: Regulation of craving |
| CONTROL (NO REGULATION) | Placebo comparator | In the CONTROL condition, participants will first read a brief essay about a non-alcohol-related topic (e.g., color perception). Then, participants will complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will view images of objects that are unrelated to alcohol. Furthermore, participants in the control condition will not practice any strategy in the regulation of craving task (ROC-T). That is, in the CONTROL condition, participants would merely observe the image and allow natural responses to come (i.e., LOOK instruction) and rate how colorful is each item (this controls for task time and experiment setting). Receives: Behavioral: Control (NO REGULATION) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline followback (TLFB)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Measured: Baseline (first visit) to post-intervention (an average of one week after first visit)
Secondary outcomes (2)
Frequency of regulating drinking + craving.
Participants will be asked to report their craving regulation (if any) since the intervention. In order to assess the level of craving regulation the participants will answer several questions in our craving regulation questionnaire. This assessment will include questions about the number of attempts at craving regulation, the number of times the participant intended to regulate craving, one's confidence in one's ability to regulate craving, the level of motivation to regulate drinking before each drinking episode, and the participant's intention to regulate drinking in the future. Finally, participants will be asked how many times they were thinking of negative consequences in general and while experiencing alcohol craving.
Measured: Will be measured at post-intervention (one week after first visit)
Timeline followback (TLFB)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Measured: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start10 Apr 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: Study stopped due to COVID shutting down all research at Yale University.
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 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uri Berger, PhD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928626
- Sponsor's protocol ID
- 2000023367
- Status last verified
- Feb 2024
- First submitted
- 11 Apr 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief ROC Training Effects on Alcohol Drinking
- ClinicalTrials.gov ID
- NCT03928626
- Acronym / sponsor ID
- 2000023367
- Conditions
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Alcohol Drinking, Alcohol Drinking in College
- Keywords
- Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker, Regulation of craving, Cognitive behavioral therapy, Neurocognitive training, Emotion regulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to COVID shutting down all research at Yale University.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 26 Apr 2019 (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.
The goal of the proposed study is to examine whether a single session of training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of (1) a basic screening (phone and/or online) and an in-person visit, to determine eligibility and conduct pre-intervention baseline assessments; (2) a training (ROC-T) visit, (3) a post-intervention assessment visit, and (4) 1-2 phone/online follow-up assessments.
The study will take up to 10 hours of the participants' time.
Detailed description
The investigators propose to test the efficacy of such training by randomizing 120 individuals who report alcohol drinking to the following conditions: (1) a brief training in cognitive regulation and (2) a control or no-training condition. Training will be delivered in a computerized session (approximately 60 minutes). If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy while viewing images of alcoholic drinks. The strategy would be to follow instructions to think about the adverse outcomes associated with continued alcohol drinking. If randomized into the control condition, participants will only view non-alcohol-related images with no use of strategy. After all the training sessions are completed, participants will complete several follow-ups. The investigators will evaluate the effects of training on alcohol drinking pre- and post-training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRAVING REGULATION | Active comparator | Behavioral: Regulation of cravingIn the CRAVING REGULATION condition, participants will first read a brief essay about the adverse consequences of drinking alcohol. Then, participants may complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will be trained to use the information to inform the strategy they will use in the regulation of craving training (ROC-T). A single trial in the regulation of craving training will have two possible instructions: (a) STRATEGY: implement the strategy ("bring to mind the negative facts from the essay") and (b) LOOK: to merely observe the image and allow natural responses to come. Participants will follow the instructions; followed by an alcohol-related picture, a brief delay, and will then rate their craving. Participants will then be instructed to use this strategy in daily life situations when they might drink. |
| CONTROL (NO REGULATION) | Placebo comparator | Behavioral: Control (NO REGULATION)In the CONTROL condition, participants will first read a brief essay about a non-alcohol-related topic (e.g., color perception). Then, participants will complete a comprehension check consisting of questions to ensure that they understood and encoded the content of the essays. Participants will view images of objects that are unrelated to alcohol. Furthermore, participants in the control condition will not practice any strategy in the regulation of craving task (ROC-T). That is, in the CONTROL condition, participants would merely observe the image and allow natural responses to come (i.e., LOOK instruction) and rate how colorful is each item (this controls for task time and experiment setting). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults ages 18-25
- Capability of performing the experimental tasks (e.g., can read, able to use computers)
- Native or fluent speaker of English
- Provides informed consent
- Normal or corrected-to-normal vision
Key exclusion criteria (4 listed)
- Present DSM disorders, apart from alcohol use disorders
- Reports of neurological or systemic disorders that can cause cognitive impairment
- Minor cognitive impairment evidenced by an inability to correctly understand study information
- Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation Ladder score of 9 or 10).
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 |
|---|---|---|
| Regulation of cravingAlso: Neurocognitive trainingParticipants in the ROC-T condition will be trained to use a strategy that instructs them to think of the negative outcomes associated with alcohol drinking while looking at alcohol-related images. | Behavioural | CRAVING REGULATION |
| Control (NO REGULATION)Also: Sham (No regulation)In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come | Behavioural | CONTROL (NO REGULATION) |
Primary outcome
Timeline followback (TLFB)
Time frame: Baseline (first visit) to post-intervention (an average of one week after first visit)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
2 secondary outcomes
Frequency of regulating drinking + craving.
Time frame: Will be measured at post-intervention (one week after first visit)
Timeline followback (TLFB)
Time frame: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)
Results and safety
The study was stopped early (reason given: Study stopped due to COVID shutting down all research at Yale University.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Uri Berger, PhD study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulation of craving in people with Binge Drinking and Heavy Drinking, 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 7 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: stopped early, as of the sponsor's last update on 28 Feb 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?
The study was stopped early (reason given: Study stopped due to COVID shutting down all research at Yale University.). Results are not available in the source record.
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?
Timeline followback (TLFB) (time frame: Baseline (first visit) to post-intervention (an average of one week after first visit)). 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 28 Feb 2024.