The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-27

Study Completion Date

2023-08-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Double-blind, placebo-controlled, parallel design

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded

Study Groups

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patients receiving 300mg PREG

Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.

Group Type ACTIVE_COMPARATOR

Pregnenolone300

Intervention Type DRUG

300mg

patients receiving 500mg PREG

Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.

Group Type ACTIVE_COMPARATOR

Pregnenolone500

Intervention Type DRUG

500mg

placebo

Patients randomly assigned to receive a placebo daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Pregnenolone300

300mg

Intervention Type DRUG

Pregnenolone500

500mg

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No