Study Stopped
Enrollment paused when our alcohol supplier recalled and suspended manufacture of the product. When production resumed, there was not enough time remaining to successfully resume recruitment. We will examine the outcomes with the existing sample.
Human Alcohol Seeking Despite Aversion
2 other identifiers
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2018
CompletedFirst Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2022
CompletedResults Posted
Study results publicly available
February 25, 2025
CompletedFebruary 25, 2025
February 1, 2025
4.1 years
August 21, 2018
October 2, 2024
February 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration
Participants earn 2.5 min exposures to an increase in iv infusion rate (causing a prescribed increase in breath alcohol concentration (BRAC)) by completing repetitions of a constant attention button-pressing task (CAT). The task is designed so that the number of correct CAT trials required increases progressively from 1 (for the first drink) to 380 (for the 20th drink) on an accelerating scale. The dependent measure Breakpoint is defined as the cumulative number of correct and incorrect CAT trials completed when the last drink is earned; in the time allowed possible values ranged from 1 to 800. Effect of the Aversive cue was assessed by calculating a difference score (Breakpoint Aversive Cue-Breakpoint Neutral Cue); the range of possible difference scores was -800 to +800. A positive difference score indicates a higher breakpoint (more alcohol earned) in the Aversive Cue session; a negative number indicates a lower breakpoint (less alcohol earned).
In two infusion sessions, to occur 5-14 days apart
Study Arms (2)
Higher lifetime alcohol drinking
EXPERIMENTALParticipants with a history of higher lifetime alcohol consumption
Lower lifetime alcohol drinking
EXPERIMENTALParticipants with a lower lifetime alcohol consumption
Interventions
Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol
Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Purdue Universitycollaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (1)
University Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 40618299DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Martin H. Plawecki, MD, PhD
- Organization
- Indiana University - Indianapolis
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subjects are not informed which session will include aversive cues.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 27, 2018
Study Start
April 4, 2018
Primary Completion
May 4, 2022
Study Completion
May 4, 2022
Last Updated
February 25, 2025
Results First Posted
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will become available following final publication of all manuscripts by the component investigators. Earliest date is estimated to be January, 2025.
- Access Criteria
- Data and Resource Sharing Plan - Indiana Alcohol Research Center (IARC) Consistent with its past history, the IARC continues to make available its data and resources to investigators engaged in alcoholism research outside of Indiana University. Detailed procedures are available on request. In brief, investigators must submit a written request specifying in adequate detail the specific resource(s) required and a study protocol indicating the specific aims, scientific rationale, methods and procedure, and analysis of results; a signed IARC Resource Utilization Agreement Form; and for studies involving human subjects, Institutional Review Board (IRB) approval if needed for the proposed study. The request will be reviewed by the IARC Steering Committee. Investigators must agree to acknowledge the Indiana Alcohol Research Center (P60 AA007611) as the source of the resource in all resulting publications.
After publication of the main findings, a de-identified dataset will be made available through direct requests as described above; a statement to this effect will be included in all published manuscripts. The current proposal utilizes the Seeking Despite Aversion Task, a newly developed Computer-Assisted Infusion System (CAIS) protocol that integrates delivery of visual stimuli into the Constant Attention Task and optical markers for evoked response potential generation. This task, like other CAIS protocols, will become part of the portfolio of CAIS programs that our lab makes available to other scientists once our specific funded use of this protocol is completed. Modified versions of this protocol could be provided to other investigators prior to completion of this project as long as these projects do not directly compete.