An interventional study of Regulation of craving and Control (NO REGULATION) in Binge Drinking, Heavy Drinking and Young Adult, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 57 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Regulation of craving
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).
Behavioral: Control (NO REGULATION)
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.
Also known as: Neurocognitive training
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
Also known as: Sham (No regulation)
Timeline followback (TLFB)
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Time frame: Baseline (first visit) to post-intervention (an average of one week after first visit)
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.
Time frame: 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.
Time frame: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)
Plan to share: No — IPD will not be shared with other researchers.
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in Mar 2020, 11 months.
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This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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