Clinical trial NCT03872128: The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Official title: The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
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: 2019-03-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Double-blind, placebo-controlled, parallel design
Primary purpose: TREATMENT

Brief summary: To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with alcohol use disorder (AUD).

Detailed description: The study aims to examine the effects of PREG on a) alcohol craving, mood and neuroendocrine reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily alcohol intake, craving, cognition and mood in men and women with AUD; and c) sex differences in all of these outcomes.

Eligibility criteria: Inclusion Criteria:

* Male or female individuals, ages 18 to 68.
* Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.
* Subject has voluntarily given informed consent and signed the informed consent document.
* Able to read English and complete study evaluations.

Exclusion Criteria:

* Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
* Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.
* Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).
* Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.
* Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.
* Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
* Hypotensive individuals with sitting blood pressure below 90/50 mmHG.

Primary outcomes:
measure: Percent Drinking Days
timeFrame: up to 8 weeks
measure: Percent Heavy Drinking Days
timeFrame: up to 8 weeks
measure: Number of Drinks Per Drinking Day
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Alcohol Craving
timeFrame: 8 week outcome period
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: up to 8 weeks
measure: Pregnenolone Levels
timeFrame: up to 8 weeks
measure: Weekly Negative Mood and Anxiety
timeFrame: assessed weekly, score at week 8 reported
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The Yale Stress Center: Yale University
state: Connecticut
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
References: