Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Launched by YALE UNIVERSITY · Mar 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Prazosin on individuals who have Alcohol Use Disorder (AUD) and may be experiencing withdrawal symptoms. The trial will compare Prazosin, given at a dose of 16 mg per day, to a placebo (a non-active treatment) over a 12-week period. Participants will also receive weekly counseling to help support their recovery. Researchers want to see how many days participants go without heavy drinking and how their cravings, mood, anxiety, and sleep issues change during the study.

To be eligible for this trial, participants need to have a history of alcohol withdrawal symptoms and meet specific criteria for moderate to severe AUD. They should be regular drinkers, using alcohol at least three times a week. However, this trial is open to both those who need medical detoxification and those who do not. It's important for participants to be able to read and understand English and to provide consent for their involvement. If you or someone you know is interested in participating, this study offers a structured way to potentially improve drinking habits with medical support.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Alcohol Withdrawal (AW) scores of 3 or more on the CIWA-Ar at treatment entry and 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 Disorder (AUD) using SCID-I for DSM-5;
• • No health conditions that would impact trial participation as verified by screening and physical examination;
• • 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 any another psychoactive substance, excluding nicotine;
• • Current use of opioids or past history of opioid use disorder;
• • Regular use of anticonvulsants, sedatives/hypnotics, oral prescription analgesics (other than noon-steroidal antiinflammatory drugs), other antihypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, acamprosate, naltrexone, antabuse, topiramate, gabapentin, baclofen, varenicline;
• • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
• • 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;
• • Any psychotic disorder or current Axis I psychiatric disorders requiring specific attention, including need for psychiatric medications;
• • Hypotensive individuals with sitting blood pressure below 100/50 mmHG;
• • Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).