PARS: Perceived Alcohol Rewards and Risks Study

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT04710095
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 60
• Arms: 2
• Actual Duration (Months): 16.7

Study Details

Study Description

Brief Summary

The identification of mechanisms that underlie how people reduce or eliminate alcohol use is a critical public health issue. Understanding these mechanisms can inform how to effectively intervene with problem drinkers. Thus far it has been a challenge for the alcohol research field to find consistent empirical evidence in support of candidate mechanisms of behavior change. Scientific advancement in this area may be aided by longitudinal transdisciplinary research on the interplay between behavioral intervention, cognition, and brain activity to understand underlying processes of behavior change among heavy drinkers. This study employed a randomized 2-arm repeated measures design with a sample of non-treatment seeking adult heavy drinkers to examine changes in perceived reward value and risks of alcohol use as a mechanism of alcohol behavior change after a brief behavioral intervention. Participants were randomized to either a 1-session behavioral intervention or to an attention-matched control condition and immediately after completed an fMRI scan. The focus of this project is to examine if group differences in perceived alcohol reward value after the intervention mediates an intervention effect on reducing alcohol use in the 1 month following the intervention.

Condition or Disease	Intervention/Treatment	Phase
Heavy Drinking	Behavioral: Brief Alcohol Intervention; Behavioral: Control Condition	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Perceived Alcohol Reward Value and Risk: Neural Correlates and Treatment Effects
• Actual Study Start Date: Nov 13, 2015
• Actual Primary Completion Date: Apr 5, 2017
• Actual Study Completion Date: Apr 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Brief Alcohol Intervention A brief intervention consisting of a 30-45 minute individual face-to-face session based on the principles of motivational interviewing.	Behavioral: Brief Alcohol Intervention; Brief alcohol intervention uses a motivational interviewing approach and covers the following components: giving information about the possible health risks associated with alcohol use, placing the responsibility for change on the individual, discussing the reasons for drinking and downsides of drinking, and setting a goal and change plan if the participant is receptive.
Sham Comparator: Attention-Matched Control Condition Brief attention-matched control condition.	Behavioral: Control Condition; The attention-matched control condition consisting of a 30-min video about astronomy.

Outcome Measures

Primary Outcome Measures

1. Percent Heavy Drinking Days [4 weeks post intervention]

   Percent heavy drinking days defined as 5+ drinks for men and 4+ for women according to self-reported Timeline Follow Back (TLFB) data

2. Neural Alcohol Cue Reactivity [Single time point immediately post intervention]

   Neural alcohol cue reactivity as measured by whole brain activation to alcohol taste cue vs. water taste cue using functional magnetic resonance imaging (fMRI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. engaged in regular heavy drinking, as indicated by consuming 5 or more drinks per occasion for men or 4 or more drinks per occasion for women at least 4 times in the month prior to enrollment

2. a score of ≥ 8 on the Alcohol Use Disorder Identification Test (AUDIT)

Exclusion Criteria:

1. under the age of 21

2. currently receiving treatment for alcohol problems, history of treatment in the 30 days before enrollment, or currently seeking treatment

3. a positive urine toxicology screen for any drug other than cannabis

4. a lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder

5. serious alcohol withdrawal symptoms

6. history of epilepsy, seizures, or severe head trauma

7. non-removable ferromagnetic objects in body

8. claustrophobia

9. pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, Los Angeles
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Lara A Ray, PhD, University of California, Los Angeles
• Principal Investigator: Mitchell P Karno, PhD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lara Ray, PhD, Co-Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04710095
• Other Study ID Numbers: IRB#15-000237; R21AA023669
• First Posted: Jan 14, 2021
• Last Update Posted: Jan 25, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 25, 2021