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

NCT03872128 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16080181791R01AA026514-01A1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• Percent Drinking Days

  The mean percent drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.

  up to 8 weeks

• Percent Heavy Drinking Days

  The mean percent heavy drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.

  up to 8 weeks

• Number of Drinks Per Drinking Day

  Average number of drinks per drinking day as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.

  up to 8 weeks

Secondary Outcomes (4)

• Alcohol Craving

  8 week outcome period

• Number of Participants With Treatment Emergent Adverse Events

  up to 8 weeks

• Pregnenolone Levels

  up to 8 weeks

• Weekly Negative Mood and Anxiety

  assessed weekly, score at week 8 reported

Study Arms (3)

patients receiving 300mg PREG

ACTIVE COMPARATOR

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

Drug: Pregnenolone300

patients receiving 500mg PREG

ACTIVE COMPARATOR

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

Drug: Pregnenolone500

placebo

PLACEBO COMPARATOR

Patients randomly assigned to receive a placebo daily.

Drug: Placebo

Interventions

Pregnenolone300 DRUG

300mg

patients receiving 300mg PREG

Pregnenolone500 DRUG

500mg

patients receiving 500mg PREG

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

Location

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Nia Fogelman
• Organization: Yale University

nia.fogelman@yale.edu

(917)861-9865

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Double-blind, placebo-controlled, parallel design

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: March 13, 2019
• Study Start: September 27, 2018
• Primary Completion: November 1, 2022
• Study Completion: August 1, 2023
• Last Updated: February 5, 2024
• Results First Posted: December 15, 2023

Record last verified: 2024-02

Locations

US (2)