Clinical trial NCT03648840: Human Alcohol Seeking Despite Aversion
Official title: Human Alcohol Seeking Despite Aversion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-08-27
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 session crossover, random order, single blind
Primary purpose: BASIC_SCIENCE

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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Effect of Exposure to Aversive Cues on IV Alcohol Self-administration
timeFrame: In two infusion sessions, to occur 5-14 days apart
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
affiliation: Psychiatry, Indiana University School of Medicine
name: Martin H Plawecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychology, Indiana University-Purdue University at Indianapolis
name: Melissa A Cyders, PhD
role: PRINCIPAL_INVESTIGATOR
References: