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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pregnenolone300
Pregnenolone500
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 - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

patients receiving 300mg PREG

patients receiving 500mg PREG

placebo

Arm Description

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

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

Patients randomly assigned to receive a placebo daily.

Outcomes

Primary Outcome Measures

Reduce alcohol use
Change in any drinking days, percent heavy drinking days as well as 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.

Secondary Outcome Measures

Alcohol craving
Alcohol craving assessed using the weekly Obsessive Compulsive Drinking Scale.
Adverse Events
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.
Pregnenolone levels
blood levels of study drug at 3 timepoints during the trial
Weekly Negative mood and anxiety
The Hospital Anxiety and Depression Scale (HADS) will be used; it is a 7 item, brief measure of generalized symptoms of anxiety and fear. Respondents indicate how they currently feel and responses are rated on a 4-point Likert scale and range from 0 to 3.

Full Information

First Posted
February 1, 2019
Last Updated
October 23, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03872128
Brief Title
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Official Title
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
August 1, 2023 (Actual)

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
No

5. Study Description

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).
Detailed Description
The study aims to examine the effects of PREG on a) alcohol craving, mood and neuroendocrine reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily alcohol intake, craving, cognition and mood in men and women with AUD; and c) sex differences in all of these outcomes.

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 1
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
91 (Actual)

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
patients receiving 500mg PREG
Arm Type
Active Comparator
Arm Description
Patients randomly assigned to receive 500mg 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)
Pregnenolone300
Intervention Description
300mg
Intervention Type
Drug
Intervention Name(s)
Pregnenolone500
Intervention Description
500mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Reduce alcohol use
Description
Change in any drinking days, percent heavy drinking days as well as 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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Alcohol craving
Description
Alcohol craving assessed using the weekly Obsessive Compulsive Drinking Scale.
Time Frame
8 week outcome period
Title
Adverse Events
Description
The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.
Time Frame
8 weeks
Title
Pregnenolone levels
Description
blood levels of study drug at 3 timepoints during the trial
Time Frame
During 8 week period
Title
Weekly Negative mood and anxiety
Description
The Hospital Anxiety and Depression Scale (HADS) will be used; it is a 7 item, brief measure of generalized symptoms of anxiety and fear. Respondents indicate how they currently feel and responses are rated on a 4-point Likert scale and range from 0 to 3.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
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

Learn more about this trial

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

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