Brief ROC Training Effects on Alcohol Drinking

NCT ID: NCT03928626

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2020-03-15

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Regulation of craving

Intervention Type BEHAVIORAL

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)

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).

Group Type PLACEBO_COMPARATOR

Control (NO REGULATION)

Intervention Type BEHAVIORAL

In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come

Interventions

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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.

Intervention Type BEHAVIORAL

Control (NO REGULATION)

In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come

Intervention Type BEHAVIORAL

Other Intervention Names

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Neurocognitive training Sham (No regulation)

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uri Berger, PhD

Role: STUDY_DIRECTOR

Yale University

Locations

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Clinical & Affective Neuroscience Lab

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000023367

Identifier Type: -

Identifier Source: org_study_id

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