Pregnenolone for the Treatment of Alcohol Use Disorder

Study Overview
=================
Brief Summary
-----------------
This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).

Detailed Description
-----------------
In this Phase 2 single-site randomized controlled trial (RCT), men and women with Alcohol Use Disorder (AUD) will be enrolled in a 12 week trial with a 1-month follow-up assessment. Participants will be randomly assigned to 300mg pregnenolone (PREG) treatment b.i.d., or Placebo (PBO). All participants will be assessed 2x weekly and also receive behavior counseling to support recovery. The study aims to examine a) the safety and tolerability; b) efficacy on alcohol use outcomes; and c) effects on alcohol craving, anxiety, depression and physical well-being of 300mg PREG vs. PBO in men and women with AUD over the 12-week treatment period and at the 1-month follow up post-treatment period.

Official Title
-----------------
Pregnenolone for the Treatment of Alcohol Use Disorder

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Drug: Pregnenolone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female individuals, ages 18 to 70. Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Double-blind, placebo-controlled, parallel design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients receiving 300mg PREG<br>Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily. | Drug: Pregnenolone<br>* 300mg<br>|
| Placebo Comparator: placebo<br>Patients randomly assigned to receive a placebo daily. | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects with no Heavy Drinking Days | Pregnenolone versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period. | 12 weeks | 
| Safety of pregnenolone | The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Heavy Drinking Days | Percent of overall days with heavy drinking days (defined by 5 or more drinks per day in men and 4 or more drinks/day in women). | 12 weeks | 
| Percent Any Drinking Days | Percent of any drinking days over a 12 week period. | 12 weeks | 
| Average Drinks per Day | The average number of drinks consumed per day assessed weekly over the treatment period. | 12 weeks |