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Phase Pilot

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

  • Study HIC#:1608018179
  • Last Updated:04/07/2022

The proposed study will enroll 90 treatment seeking individuals with alcohol use disorder (45 Men; 45 Women), who will be randomized to receive either 300mg pregnenolone (n=30), 500mg pregnenolone (n=30) or placebo (n=30) in a double blind manner, for 8 weeks. Throughout the trial, subjects will visit the Yale Stress Center for twice-weekly appointments to assess alcohol use outcomes in person and also via daily smartphone monitoring. In week 2, participants will be exposed to 3 laboratory sessions of guided imagery conditions (stress, drug cue and neutral); one per day across consecutive days in a counterbalanced and random order.

 

  • Age18 years - 60 years
  • GenderBoth
  • Start Date10/22/2018
  • End Date06/30/2023

Trial Purpose and Description

To use pregnenolone (PREG; 400mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with alcohol use disorder (AUD). The study aims to examine the effects of PREG on a) alcohol craving, behavioral alcohol motivation and intake, mood and neuroendocrinel reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily alcohol intake, craving and mood in men and women with AUD; and c) sex differences in all of these outcomes. We hypothesize that PREG vs PLA will decrease stress-induced and drug-cue induced alcohol craving, behavioral alcohol motivation and intake and normalize HPA axis response to stress and drug-cue imagery in the laboratory, and also reduce alcohol intake and craving in daily life in individuals with AUD.

Eligibility Criteria

Inclusion Criteria:

i. Male or female individuals, ages 18 to 60.

ii. Subjects must meet current 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.

iii. Subject has voluntarily given informed consent and signed the informed consent

document.

iv. Able to read English and complete study evaluations.

 

Exclusion Criteria:

i. Women who are pregnant, or nursing or are of childbearing potential and not practicing an

effective means of birth control.

ii. Meet current criteria for use disorder on another psychoactive substance, such as, heroin,

amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.

iii. Any current use of opiates or past history of opiate use disorder (assessed via urine

toxicology and self report).

iv. Current use of any psychoactive drugs (urine toxicology), including anxiolytics,

antidepressants, naltrexone or antabuse.

v. Any psychotic disorder or current Axis I psychiatric symptoms requiring specific

attention, including need for psychiatric medications for current major depression and

anxiety disorders.

vi. 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.

viii. Hypotensive individuals with sitting blood pressure below 90/50 mmHG.

Principal Investigator

Sub-Investigator

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