Human Alcohol Seeking Despite Aversion

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03648840
Collaborator
Purdue University (Other)
100
1
3
59
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aversive cue
  • Behavioral: Neutral cue
N/A

Detailed Description

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
2 session crossover, random order, single blind2 session crossover, random order, single blind
Masking:
Single (Participant)
Masking Description:
Subjects are not informed which session will include aversive cues.
Primary Purpose:
Basic Science
Official Title:
Human Alcohol Seeking Despite Aversion
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Higher lifetime alcohol drinking

Half of the participants will have a history of higher lifetime alcohol consumption; all will participate in both interventions (Aversive cue, Neutral cue).

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

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

Other: Lower lifetime alcohol drinking

Half of the participants will have a history of lower lifetime alcohol consumption; all will participate in both interventions (Aversive cue, Neutral cue).

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

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

Other: Resting state connectivity

Some participants will also complete a functional magnetic resonance imaging (fMRI) session to determine resting state connectivity. All participants in this Arm will have completed both of the iv alcohol self-administration sessions (Aversive cue, Neutral cue).

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

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

Outcome Measures

Primary Outcome Measures

  1. IV alcohol self-administration [Within session]

    Between session differences in self-administration will be evaluated using progressive work breakpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Higher or lower lifetime alcohol drinking history

  • Able to understand and complete questionnaires and procedures in English

  • BMI between 18.5 and 32

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University
  • Purdue University

Investigators

  • Principal Investigator: Martin H Plawecki, MD, PhD, Psychiatry, Indiana University School of Medicine
  • Principal Investigator: Melissa A Cyders, PhD, Psychology, Indiana University-Purdue University at Indianapolis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martin Plawecki, Assistant Professor of Psychiatry, Indiana University
ClinicalTrials.gov Identifier:
NCT03648840
Other Study ID Numbers:
  • 1709318986
First Posted:
Aug 27, 2018
Last Update Posted:
Mar 29, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022