Status:
COMPLETED
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-68 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03872128
Start Date
September 27 2018
End Date
August 1 2023
Last Update
February 5 2024
Active Locations (2)
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1
The Yale Stress Center: Yale University
New Haven, Connecticut, United States, 06519
2
Yale Stress Center
New Haven, Connecticut, United States, 06519