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

Yale University

Status and phase: Completed; Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Pregnenolone300; Drug: Placebo; Drug: Pregnenolone500

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03872128

1R01AA026514-01A1 (U.S. NIH Grant/Contract)

1608018179

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups, including a placebo group

patients receiving 300mg PREG

Active Comparator group

Description:

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

Treatment:

Drug: Pregnenolone300

patients receiving 500mg PREG

Active Comparator group

Description:

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

Treatment:

Drug: Pregnenolone500

placebo

Placebo Comparator group

Description:

Patients randomly assigned to receive a placebo daily.

Treatment:

Drug: Placebo