Phase 1
N=91
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03872128 ↗Enrolled (actual)
91
Serious AEs
1.2%
Results posted
Dec 2023
Primary outcome: Primary: Percent Drinking Days — 38.5; 46.6; 53 percentage of drinking days — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Pregnenolone300 (Drug); Pregnenolone500 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Drinking Days |
38.5; 46.6; 53 | 0.009 sig |
| PRIMARY Percent Heavy Drinking Days |
15.2; 23.7; 22.9 | 0.019 sig |
| PRIMARY Number of Drinks Per Drinking Day |
1.7; 2.5; 2.3 | 0.044 sig |
| SECONDARY Alcohol Craving |
13.8; 16.2; 20.4; 4; 5.8; 6.9 | <0.001 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
10; 9; 8 | — |
| SECONDARY Pregnenolone Levels |
5.46; 6.21; 2.42 | <.0001 sig |
| SECONDARY Weekly Negative Mood and Anxiety |
4.53; 4.85; 6.55; 5.36; 6.49; 7.31 | <0.001 sig |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03872128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.