Pregnenolone for the Treatment of Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Pregnenolone for the Treatment of Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781009
• Other study ID #: 2000034929
• Secondary ID: 1R01AA030923-01
• Status: Recruiting
• Phase: Phase 2
• Start date: January 8, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Verica Milivojevic, PhD
• Phone: 203-737-1176
• Email: verica.milivojevic[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Pregnenolone
300mg
• Placebo
placebo

Locations

Country	Name	City	State
United States	The Yale Stress Center: Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Percent Any Drinking Days	Percent of any drinking days over a 12 week period.	12 weeks
Secondary	Average Drinks per Day	The average number of drinks consumed per day assessed weekly over the treatment period.	12 weeks