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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04710095
Other study ID # IRB#15-000237
Secondary ID R21AA023669
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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