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

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.

Inclusion Criteria:

- Male or female individuals, ages 18 to 60.

- 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,
antidepressants, naltrexone or antabuse.

- Any psychotic disorder or current Axis I psychiatric symptoms requiring specific
attention, including need for psychiatric medications for current major depression and
anxiety disorders.

- 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.