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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03872128
• Collaborator: (none)
• Enrollment: 91
• Locations: 2
• Arms: 3
• Actual Duration (Months): 44.6
• Patients Per Site: 45.5
• Patients Per Site Per Month: 1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Pregnenolone300; Drug: Pregnenolone500; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 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: The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
• Actual Study Start Date: Sep 27, 2018
• Actual Primary Completion Date: Jun 17, 2022
• Actual Study Completion Date: Jun 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: patients receiving 300mg PREG Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.	Drug: Pregnenolone300; 300mg
Active Comparator: patients receiving 500mg PREG Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.	Drug: Pregnenolone500; 500mg
Placebo Comparator: placebo Patients randomly assigned to receive a placebo daily.	Drug: Placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Reduce alcohol use [8 weeks]

   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

1. Alcohol craving [8 week outcome period]

   Alcohol craving assessed daily using the Smartphone App and also using the weekly assessment of the Alcohol Urge Questionnaire-Brief (AUQ-Brief).

2. Adverse Events [8 weeks]

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

3. Pregnenolone levels [During 8 week period]

   blood levels of study drug at 3 timepoints during the trial

4. Weekly Negative mood and anxiety [8 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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: NCT03872128
• Other Study ID Numbers: 1608018179
• First Posted: Mar 13, 2019
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• 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 Jun 27, 2022