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Alcohol-ROC-Training

Recruiting
18 - 26 years of age
Both
Phase N/A

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Overview

The goal of the proposed study is to examine whether brief training in regulation of craving (ROC-T) affects alcohol drinking. The study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (ROC-T) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.The two active conditions of ROC-T are based on cognitive-behavioral treatments (CBT) and mindfulness-based treatments (MBT).

Description

This is a Stage 1B Randomized-Controlled Trial (RCT). 177 heavy drinking young adult participants will be randomized to 4 x 45-minute web-based sessions of (1) CBT-ROC-T training, (2) MBT-ROC-T, or (3) CONTROL (no strategy) delivered over three weeks. Participants will be enrolled for 16 weeks (three weeks pre-, three weeks during, and ten weeks post-intervention).

Eligibility

Inclusion Criteria:

        (1) Young adults ages 18-26 years, who (2) report ≥ 3 heavy drinking days (i.e., heavy
        drinking defined by >3 drinks for women, >4 drinks for men) in the prior month; (3) are
        motivated to quit or reduce drinking; (4) are fluent in English and have a 6th grade or
        higher reading level; (5) have access to a computer with working internet; (6) use a
        working smartphone; (7) can commit to the full length of the protocol; and (8) are willing
        to be randomized to intervention condition.
        Exclusion Criteria:
        (1) Current (past 12 months) clinically-severe alcohol use disorder (AUD; e.g., history of
        seizures, delirium, or hallucinations during withdrawal) or current severe alcohol
        withdrawal; (2) Current (past 12 months) clinically-severe substance use disorder (except
        tobacco) or current severe drug withdrawal; (3) serious other psychiatric illness by
        history or examination; (4) severe or unstable physical disease within the past 6 months;
        (5) psychoactive medications (e.g., mood stabilizers) that have not been at a stable dose
        unless determined to be on a stable dose of medication by the study psychiatrist; (6)
        current use of any investigational medication; (7) color blindness; (8) biological females
        who are pregnant; and (9) notable dislike to any particular type of alcoholic beverage
        depicted in study stimuli; (10) Participants who will not complete at least 70% of past day
        EMA reports in the pre-intervention phase will not be randomized; (11) Participants who
        cannot understand or follow study-related instructions (e.g., unable to correctly use the
        intervention strategies, indicate lack of understanding of study instructions despite
        multiple attempts).

Study details

Binge Drinking, Heavy Drinking, Young Adult, Heavy Drinker

NCT05491551

Yale University

16 February 2024

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