Brief ROC Training Effects on Alcohol Drinking

NCT03928626 | Terminated

• 1 other identifier: 2000023367
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Binge Drinking; Heavy Drinking; Young Adult; Heavy Drinker; Regulation of craving; Cognitive behavioral therapy; Neurocognitive training; Emotion regulation; Alcohol

Outcome Measures

Primary Outcomes (1)

• Timeline followback (TLFB)

  The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.

  Baseline (first visit) to post-intervention (an average of one week after first visit)

Secondary Outcomes (2)

• Frequency of regulating drinking + craving.

  Will be measured at post-intervention (one week after first visit)

• Timeline followback (TLFB)

  First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)

Study Arms (2)

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.

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).

Behavioral: Control (NO REGULATION)

Interventions

Regulation of craving 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.

Also known as: Neurocognitive training

CRAVING REGULATION

Control (NO REGULATION) BEHAVIORAL

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

Also known as: Sham (No regulation)

CONTROL (NO REGULATION)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Clinical & Affective Neuroscience Lab

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Binge Drinking; Alcoholic Intoxication; Alcohol Drinking; Alcohol Drinking in College; Drinking Behavior; Alcoholism; Emotional Regulation

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Mental Disorders; Self-Control; Social Behavior

Study Officials

• Uri Berger, PhD

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 26, 2019
• Study Start: April 10, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)