Perceived Alcohol Rewards and Risks Study

Heavy Drinking Clinical Trial

— PARS  

Official title:

Perceived Alcohol Reward Value and Risk: Neural Correlates and Treatment Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710095
• Other study ID #: IRB#15-000237
• Secondary ID: R21AA023669
• Status: Completed
• Phase: N/A
• Start date: November 13, 2015
• Est. completion date: April 5, 2017

Study information

• Verified date: January 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heavy Drinking

Intervention

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.
• Control Condition
The attention-matched control condition consisting of a 30-min video about astronomy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (2)

Grodin EN, Lim AC, MacKillop J, Karno MP, Ray LA. An Examination of Motivation to Change and Neural Alcohol Cue Reactivity Following a Brief Intervention. Front Psychiatry. 2019 Jun 11;10:408. doi: 10.3389/fpsyt.2019.00408. eCollection 2019. — View Citation

Grodin EN, Ray LA, MacKillop J, Lim AC, Karno MP. Elucidating the Effect of a Brief Drinking Intervention Using Neuroimaging: A Preliminary Study. Alcohol Clin Exp Res. 2019 Feb;43(2):367-377. doi: 10.1111/acer.13941. Epub 2019 Jan 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Heavy Drinking Days	Percent heavy drinking days defined as 5+ drinks for men and 4+ for women according to self-reported Timeline Follow Back (TLFB) data	4 weeks post intervention
Primary	Neural Alcohol Cue Reactivity	Neural alcohol cue reactivity as measured by whole brain activation to alcohol taste cue vs. water taste cue using functional magnetic resonance imaging (fMRI)	Single time point immediately post intervention