Pregnenolone for the Treatment of Alcohol Use Disorder

• Sponsor: Yale University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05781009
• Collaborator: (none)
• Enrollment: 150
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site: 75
• Patients Per Site Per Month: 1.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Pregnenolone; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Double-blind, placebo-controlled, parallel designRandomized Double-blind, placebo-controlled, parallel design
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blinded
• Primary Purpose: Treatment
• Official Title: Pregnenolone for the Treatment of Alcohol Use Disorder
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2028
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: patients receiving 300mg PREG Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.	Drug: Pregnenolone; 300mg
Placebo Comparator: placebo Patients randomly assigned to receive a placebo daily.	Drug: Placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Percent of Subjects with no Heavy Drinking Days [12 weeks]

   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.

2. Safety of pregnenolone [12 weeks]

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

Secondary Outcome Measures

1. Percent Heavy Drinking Days [12 weeks]

   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).

2. Percent Any Drinking Days [12 weeks]

   Percent of any drinking days over a 12 week period.

3. Average Drinks per Day [12 weeks]

   The average number of drinks consumed per day assessed weekly over the treatment period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Yale Stress Center: Yale University	New Haven	Connecticut	United States	06519
2	Yale Stress Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT05781009
• Other Study ID Numbers: 1608018179_a
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• 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
• Additional relevant MeSH terms: Alcoholism; Alcohol Drinking

Study Results

No Results Posted as of Mar 23, 2023