Clinical trial NCT04710095: Perceived Alcohol Rewards and Risks Study
Official title: Perceived Alcohol Reward Value and Risk: Neural Correlates and Treatment Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: 4 weeks post intervention
measure: Neural Alcohol Cue Reactivity
timeFrame: Single time point immediately post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Lara A Ray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Mitchell P Karno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Meredith LR, Grodin EN, Karno MP, Montoya AK, MacKillop J, Lim AC, Ray LA. Preliminary study of alcohol problem severity and response to brief intervention. Addict Sci Clin Pract. 2021 Aug 24;16(1):54. doi: 10.1186/s13722-021-00262-6.