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Pregnenolone for the Treatment of Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pregnenolone
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Yale Stress Center: Yale University
  • Yale Stress Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

patients receiving 300mg PREG

placebo

Arm Description

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

Patients randomly assigned to receive a placebo daily.

Outcomes

Primary Outcome Measures

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.
Safety of pregnenolone
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.

Secondary Outcome Measures

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).
Percent Any Drinking Days
Percent of any drinking days over a 12 week period.
Average Drinks per Day
The average number of drinks consumed per day assessed weekly over the treatment period.

Full Information

First Posted
March 10, 2023
Last Updated
September 28, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05781009
Brief Title
Pregnenolone for the Treatment of Alcohol Use Disorder
Official Title
Pregnenolone for the Treatment of Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double-blind, placebo-controlled, parallel design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients receiving 300mg PREG
Arm Type
Active Comparator
Arm Description
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomly assigned to receive a placebo daily.
Intervention Type
Drug
Intervention Name(s)
Pregnenolone
Intervention Description
300mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Percent of Subjects with no Heavy Drinking Days
Description
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.
Time Frame
12 weeks
Title
Safety of pregnenolone
Description
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent Heavy Drinking Days
Description
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).
Time Frame
12 weeks
Title
Percent Any Drinking Days
Description
Percent of any drinking days over a 12 week period.
Time Frame
12 weeks
Title
Average Drinks per Day
Description
The average number of drinks consumed per day assessed weekly over the treatment period.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Verica Milivojevic, PhD
Phone
203-737-1176
Email
verica.milivojevic@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rajita Sinha, PHD
Phone
203-737-5805
Email
rajita.sinha@yale.edu
Facility Information:
Facility Name
The Yale Stress Center: Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Yale Stress Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Pregnenolone for the Treatment of Alcohol Use Disorder

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