Clinical trial NCT04015869: Effect of Allopregnanolone on Stress-induced Craving
Official title: Effect of Allopregnanolone on Stress-induced Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-11
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.

Detailed description: This is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk" drinkers to 2 groups: targeted dose of targeted dose of 100 nM of ALLO (N=30) or placebo (N=30). Participants will receive a continuous infusion of ALLO (or placebo) for 175 min. Sixty min. after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Participants will be presented with a stress cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5 min. scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 min after (recovery).The study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.

Eligibility criteria: Inclusion Criteria:

* Non-treatment seeking individuals with current DSM-5 AUD
* No current substance use disorder (except tobacco, alcohol, and marijuana)
* No current medical problems and normal ECG
* For women, not pregnant as determined by pregnancy screening, not breast feeding.

Exclusion Criteria:

* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
* History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
* Liver function tests (ALT or AST) greater than 3 times normal
* weight \>120kg
* renal impairment
* patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals

Primary outcomes:
measure: Alcohol Urge Questionnaire (AUQ)
timeFrame: 15 minutes
measure: The State-Trait Anxiety Inventory (STAI-6)
timeFrame: 15 minutes
Secondary outcomes:
measure: Biphasic Alcohol Effects scale (BAES)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healtcase System
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth Ralevski, PhD
role: PRINCIPAL_INVESTIGATOR
References: