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OpenTrials
Completed

NCT Number: NCT04710095

Perceived Alcohol Rewards and Risks Study

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • under the age of 21
  • currently receiving treatment for alcohol problems, history of treatment in the 30 days before enrollment, or currently seeking treatment
  • a positive urine toxicology screen for any drug other than cannabis
  • a lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
  • serious alcohol withdrawal symptoms
  • history of epilepsy, seizures, or severe head trauma
  • non-removable ferromagnetic objects in body
  • claustrophobia
  • pregnancy

Treatment and study plan

Brief alcohol intervention

Behavioral

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

Behavioral

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

Primary outcomes

  1. Percent Heavy Drinking Days

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: PARS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2021
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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