Pregnenolone for the Treatment of Alcohol Use Disorder

Inclusion Criteria:

• Male and females, aged 18-70 years;

• Regular weekly use of alcohol at least 3X weekly or more at treatment entry;

• Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorders (AUDs)using SCID-I for DSM-5;

• No health conditions that would impact trial participation as verified by screeningand physical examination and absence of any of the exclusion criterions outlinedbelow;

• Able to read English and complete study evaluations;

• Able to provide informed written and verbal consent.

Exclusion Criteria:

• Meet current criteria for moderate to severe substance use disorders from use of anyother psychoactive substance, excluding nicotine and cannabis use disorder;

• Current use of opioids;

• Regular use of anticonvulsants, sedatives or hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), topiramate, baclofen;

• Regular use of steroidal supplements and steroid medications interacting with studymedications based on clinical judgement of study physician (excluding hormonalcontraceptives in women);

• Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal,current mania);

• Significant underlying medical conditions such as cerebral, renal, thyroid orcardiac pathology which in the opinion of study physician would preclude patientfrom fully cooperating or be of potential harm during the course of the study, butstable, prescribed anti-hypertensives. cardiovascular and diabetes medications willbe allowed after review by study physician;

• Any psychotic disorder or current Axis I psychiatric disorders requiring specificacute attention, including need for psychiatric medications, but stable, prescribedantidepressants and anti-anxiety medication to treat co-occurring psychiatricdisorders will be allowed;

• Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by urine pregnancy tests during initial medical evaluation, andassessed every two weeks during the course of the study).