Human Alcohol Seeking Despite Aversion

Alcohol Abuse Clinical Trial

Official title:

Human Alcohol Seeking Despite Aversion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03648840
• Other study ID #: 1709318986
• Secondary ID: P60AA007611
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

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