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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Brief ROC Training Effects on Alcohol Drinking

Clinicaltrials.gov identifier NCT03928626

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted May 28, 2020

Study Description

Brief 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 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.

  • Condition or Disease:Binge Drinking
    Young Adult
    Heavy Drinker
    Alcohol Drinking
    Alcohol Drinking in College
    Drinking Behavior
    Drunkenness
    Drinking Excessive
    Drinking Problem
    Drink Too Much
    College Drinking
    Heavy Drinking
  • Intervention/Treatment: Behavioral: Regulation of craving
    Behavioral: Control (NO REGULATION)
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Brief ROC Training Effects on Alcohol Drinking
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: December 2023
Arms and interventions
Arm Intervention/treatment
Active Comparator: CRAVING REGULATION
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
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.
Placebo Comparator: 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).
Behavioral: Control (NO REGULATION)
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Frequency of regulating drinking + craving. [ Time Frame: Will be measured at post-intervention (one week after first visit) ]
    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.
  • 2. Timeline followback (TLFB) [ Time Frame: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit) ]
    The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 25 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

1. Adults ages 18-25

2. Capability of performing the experimental tasks (e.g., can read, able to use
computers)

3. Native or fluent speaker of English

4. Provides informed consent

5. Normal or corrected-to-normal vision

6. Willing to commit to the full length of the protocol

7. Heavy drinking or binge-drinking

Exclusion Criteria.

1. Present DSM disorders, apart from alcohol use disorders

2. Reports of neurological or systemic disorders that can cause cognitive impairment

3. Minor cognitive impairment evidenced by an inability to correctly understand study
information

4. Reports entirely no interest in reducing the amount of drinking (Alcohol Contemplation
Ladder score of 9 or 10).

Contacts and Locations
Contacts

Contact: Hedy Kober, PhD 203-737-5641 hedy.kober@yale.edu

Contact: Uri Berger, PhD 203-298-2177 uri.berger@yale.edu

Locations

United States, Connecticut
Clinical & Affective Neuroscience Lab
New Haven

Sponsors and Collaborators

Yale University

Investigators

Study Director: Uri Berger, PhD Yale University

More Information
  • Responsible Party: Yale University
  • ClinicalTrials.gov Identifier: NCT03928626 History of Changes
  • Other Study ID Numbers: 2000023367
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: May 28, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: IPD will not be shared with other researchers.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Yale University: Binge Drinking
    Heavy Drinking
    Young Adult
    Heavy Drinker
    Regulation of craving
    Cognitive behavioral therapy
    Neurocognitive training
    Emotion regulation
    Alcohol
  • Additional relevant MeSH terms: Alcoholic Intoxication
    Alcohol Drinking in College
    Alcohol Drinking
    Drinking Behavior
    Binge Drinking