Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Alcohol Seeking Despite Aversion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648840
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Purdue University
Information provided by (Responsible Party):
Martin Plawecki, Indiana University

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
Alcohol Abuse Behavioral: Aversive cue Behavioral: Neutral cue Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 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 : April 1, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  1. IV alcohol self-administration [ Time Frame: Within session ]
    Between session differences in self-administration will be evaluated using progressive work breakpoint



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648840


Contacts
Layout table for location contacts
Contact: Ann E Kosobud, PhD 3172740087 akosobud@iupui.edu

Locations
Layout table for location information
United States, Indiana
University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Study Recruiter    317-948-6551    erptest@iupui.edu   
Principal Investigator: Martin H Plawecki, MD         
Principal Investigator: Melissa A Cyders, Ph.D.         
Sponsors and Collaborators
Indiana University
Purdue University
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Martin Plawecki, Assistant Professor of Psychiatry, Indiana University
ClinicalTrials.gov Identifier: NCT03648840     History of Changes
Other Study ID Numbers: 1709318986
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs