Clinical trial NCT03928626: Brief ROC Training Effects on Alcohol Drinking
Official title: Brief ROC Training Effects on Alcohol Drinking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Timeline followback (TLFB)
timeFrame: Baseline (first visit) to post-intervention (an average of one week after first visit)
Secondary outcomes:
measure: Frequency of regulating drinking + craving.
timeFrame: Will be measured at post-intervention (one week after first visit)
measure: Timeline followback (TLFB)
timeFrame: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Clinical & Affective Neuroscience Lab
state: Connecticut
Study officials:
affiliation: Yale University
name: Uri Berger, PhD
role: STUDY_DIRECTOR
References: