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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03648840
Other study ID # 1709318986
Secondary ID P60AA007611
Status Terminated
Phase N/A
First received
Last updated
Start date April 4, 2018
Est. completion date May 4, 2022

Study information

Verified date February 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 216
Est. completion date May 4, 2022
Est. primary completion date May 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University Hospital Indianapolis Indiana

Sponsors (3)

Lead Sponsor Collaborator
Indiana University National Institute on Alcohol Abuse and Alcoholism (NIAAA), Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary IV alcohol self-administration Between session differences in self-administration will be evaluated using progressive work breakpoint In two infusion sessions, to occur approximately 1-2 weeks apart
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