Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brief ROC Training Effects on Alcohol Drinking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03928626
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hedy Kober, Yale University

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.


Condition or disease Intervention/treatment Phase
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 Behavioral: Regulation of craving Behavioral: Control (NO REGULATION) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Brief ROC Training Effects on Alcohol Drinking
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: CRAVING REGULATION
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
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.
Other Name: Neurocognitive training

Placebo Comparator: CONTROL (NO REGULATION)
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)
In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
Other Name: Sham (No regulation)




Primary Outcome Measures :
  1. Timeline followback (TLFB) [ Time Frame: Baseline (first visit) to post-intervention (an average of one week after first visit) ]
    The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.


Secondary Outcome Measures :
  1. Frequency of regulating drinking + craving. [ Time Frame: Will be measured at post-intervention (one week after first visit) ]
    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.

  2. Timeline followback (TLFB) [ Time Frame: First visit, post-intervention (one week after first visit), follow-up (two weeks after first visit) ]
    The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928626


Contacts
Layout table for location contacts
Contact: Hedy Kober, PhD 203-737-5641 hedy.kober@yale.edu
Contact: Uri Berger, PhD 203-298-2177 uri.berger@yale.edu

Locations
Layout table for location information
United States, Connecticut
Clinical & Affective Neuroscience Lab Recruiting
New Haven, Connecticut, United States, 06510
Contact: Nilofar Vafaie, PhD    203-737-4714    nilo.vafay@yale.edu   
Principal Investigator: Hedy Kober, Ph.D.         
Sub-Investigator: Uri Berger, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Study Director: Uri Berger, PhD Yale University

Layout table for additonal information
Responsible Party: Hedy Kober, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT03928626     History of Changes
Other Study ID Numbers: 2000023367
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hedy Kober, Yale University:
Binge Drinking
Heavy Drinking
Young Adult
Heavy Drinker
Regulation of craving
Cognitive behavioral therapy
Neurocognitive training
Emotion regulation
Alcohol

Additional relevant MeSH terms:
Layout table for MeSH terms
Binge Drinking
Alcoholic Intoxication
Alcohol Drinking
Drinking Behavior
Alcohol Drinking in College
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs