Human Alcohol Seeking Despite Aversion

NCT ID: NCT03648840

Last Updated: 2025-02-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2022-05-04

Brief Summary

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Prolonged alcohol use results in drinking despite resultant problems and adverse consequences. The investigators propose to test a laboratory model of human seeking despite aversion to use as an early marker of disease onset, and as a tool for study of its neural functional substrates, and identification of effective treatments.

Detailed Description

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The long-term goal for this project is to establish a model of alcohol seeking despite aversion (SDA) as a platform for the laboratory testing of novel pharmacologic and behavioral interventions that can be used among those with the highest risk, but who have yet to progress to treatment-resistant drinking. The objective of this application is to test SDA across multiple levels of analysis. The investigators consider SDA as an early marker of alcohol use disorder progression that is related to lifetime drinking history, alcohol use disorder risks, and brain physiology. The investigators have completed a pilot study demonstrating that SDA can be objectively quantified via an intravenous alcohol self-administration task, in which operant work for identical incremental alcohol rewards is paired with aversive stimuli. This preliminary data supports the central hypotheses that behavior in the SDA model is attributable to lifetime alcohol exposure, is related to alcohol use disorder risk factors and phenotypes, and reflects alterations in neural system function. In this project, SDA will be measured along with recent and lifetime drinking history, negative affect-based rash action (i.e. negative urgency, including action with respect to alcohol use), and self-rating of the effects of alcohol. The rationale for this work is that it would lead to the first objective, well-validated measure of SDA in humans.

Conditions

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Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

2 session crossover, random order, single blind
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Subjects are not informed which session will include aversive cues.

Study Groups

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Higher lifetime alcohol drinking

Participants with a history of higher lifetime alcohol consumption

Group Type EXPERIMENTAL

Aversive Cue

Intervention Type BEHAVIORAL

Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol

Neutral Cue

Intervention Type BEHAVIORAL

Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol

Lower lifetime alcohol drinking

Participants with a lower lifetime alcohol consumption

Group Type EXPERIMENTAL

Aversive Cue

Intervention Type BEHAVIORAL

Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol

Neutral Cue

Intervention Type BEHAVIORAL

Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol

Interventions

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Aversive Cue

Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol

Intervention Type BEHAVIORAL

Neutral Cue

Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women age 21-55
* Range of lifetime alcohol drinking history from 25 kg to 500 kg, with preference for extremes, plus recent drinking at least 7 drinks/week (women) and 20 drinks/week (men)
* Able to understand and complete questionnaires and procedures in English
* Willing and able to tolerate iv placement
* Right-handed (for fMRI Arm only)

Exclusion Criteria

* Pregnant or breast-feeding
* Seeking or in treatment for substance use disorder or under court ordered abstinence
* Medications, medical disorders or conditions that could affect study outcome or subject safety
* Positive urine drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine
* Positive breath alcohol (BrAC) reading on arrival at any study visit
* Actively suicidal (within previous year)
* Left-handed or ambidextrous (for fMRI Arm only)
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Purdue University

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Martin Plawecki

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin H Plawecki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychiatry, Indiana University School of Medicine

Melissa A Cyders, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychology, Indiana University-Purdue University at Indianapolis

Locations

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University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Garrison ACS, Wu W, Cox MR, Haines D, Hays J, Mlungwana MK, Kosobud AEK, Kareken DA, O'Connor S, Plawecki MH, Cyders MA. Aversion-resistant alcohol seeking in the human laboratory. Alcohol Clin Exp Res (Hoboken). 2025 Jul;49(7):1518-1529. doi: 10.1111/acer.70078. Epub 2025 Jul 6.

Reference Type DERIVED
PMID: 40618299 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P60AA007611

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1709318986

Identifier Type: -

Identifier Source: org_study_id

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