Human Alcohol Seeking Despite Aversion

Indiana University

Status: Terminated

Conditions: Alcohol Abuse

Treatments: Behavioral: Aversive Cue; Behavioral: Neutral Cue

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03648840

1709318986

P60AA007611 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 and lifetime 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.

Enrollment: 84 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Higher lifetime alcohol drinking

Experimental group

Description:

Participants with a history of higher lifetime alcohol consumption

Treatment:

Behavioral: Neutral Cue

Behavioral: Aversive Cue

Lower lifetime alcohol drinking

Experimental group

Description:

Participants with a lower lifetime alcohol consumption

Treatment:

Behavioral: Neutral Cue

Behavioral: Aversive Cue