The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Completed · Phase 1 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
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).
Key facts
- Study ID
- NCT03872128
- Run by
- Yale University
- People needed
- 91
- Starts
- 2018-09-27
- Expected to finish
- 2023-08-01
- Last updated by the study team
- 2024-02-05
Who can join
Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The Yale Stress Center: Yale University — New Haven, Connecticut, United States
- Yale Stress Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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