Brief ROC Training Effects on Alcohol Drinking

Alcohol Drinking Clinical Trial

Official title:

Brief ROC Training Effects on Alcohol Drinking

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03928626
• Other study ID #: 2000023367
• Status: Terminated
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• Control (NO REGULATION)
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come

Locations

Country	Name	City	State
United States	Clinical & Affective Neuroscience Lab	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of regulating drinking + craving.	Participants will be asked to report their craving regulation (if any) since the intervention. In order to assess the level of craving regulation the participants will answer several questions in our craving regulation questionnaire. This assessment will include questions about the number of attempts at craving regulation, the number of times the participant intended to regulate craving, one's confidence in one's ability to regulate craving, the level of motivation to regulate drinking before each drinking episode, and the participant's intention to regulate drinking in the future. Finally, participants will be asked how many times they were thinking of negative consequences in general and while experiencing alcohol craving.	Will be measured at post-intervention (one week after first visit)
Secondary	Timeline followback (TLFB)	The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.	First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit)