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Brief ROC Training Effects on Alcohol Drinking

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Yale University

Status

Terminated

Conditions

Drunkenness
Drinking Excessive
Alcohol Drinking in College
Drinking Problem
Alcohol Drinking
Heavy Drinker
Drink Too Much
Young Adult
College Drinking
Heavy Drinking
Drinking Behavior
Binge Drinking

Treatments

Behavioral: Regulation of craving
Behavioral: Control (NO REGULATION)

Study type

Interventional

Funder types

Other

Identifiers

NCT03928626
2000023367

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 2 patient groups, including a placebo group

CRAVING REGULATION
Active Comparator group
Description:
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.
Treatment:
Behavioral: Regulation of craving
CONTROL (NO REGULATION)
Placebo Comparator group
Description:
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).
Treatment:
Behavioral: Control (NO REGULATION)

Trial contacts and locations

1

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Central trial contact

Uri Berger, PhD; Hedy Kober, PhD

Data sourced from clinicaltrials.gov

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