Alcohol-ROC-Training (A-ROC-T)

Yale University

Status: Enrolling

Conditions: Heavy Drinker; Young Adult; Heavy Drinking; Binge Drinking

Treatments: Behavioral: Mindfulness-Based Treatment-Regulation of Craving; Behavioral: Cognitive-Based Therapy-Regulation of Craving

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05491551

2000029394

1R01AA029137-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 177 estimated patients

Sex: All

Ages: 18 to 26 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 3 patient groups

Mindfulness-Based Treatment

Experimental group

Description:

Using mindfulness and meditative strategies to control craving

Treatment:

Behavioral: Mindfulness-Based Treatment-Regulation of Craving

Cognitive Behavioral Therapy

Experimental group

Description:

Thinking of negative consequences to control craving

Treatment:

Behavioral: Cognitive-Based Therapy-Regulation of Craving

Control

No Intervention group

Description:

No regulatory strategy