Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

  • STATUS
    Recruiting
  • End date
    Jun 30, 2027
  • participants needed
    150
  • sponsor
    Yale University
Updated on 26 March 2022

Summary

This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD) and history of past or current evidence of alcohol withdrawal symptoms. If medical detoxification is required for any patient, patients would be enrolled after medical detoxification. for those not requiring detoxification, they will be enrolled directly without any requirement of alcohol abstinence. All patients will be provided behavioral counseling weekly with a trained counselor to support recovery during the trial. Primary outcomes will be percent of subjects no heavy drinking days (PSNHDD) and %of any drinking and heavy drinking days as well as secondary outcomes of craving, mood, anxiety and sleep problems.

Description

In this Phase 2 single site RCT, individuals with moderate to severe alcohol use disorder (AUD) and presenc eof alcohol withdrawal symptoms (greater than 3 symptoms or more) will be enrolled in a 12 week trial with a 1- and 3- month follow up assessment. Subjects will be randomized to 16 mh /day Prazosin (PR) or Placebo (PBO) with a 2 week titration period and week 12 taper. All subjects will be assessed 2X weekly and also provided weekly behavioral counseling to support recovery.

Details
Condition Alcohol Withdrawal
Treatment Prazosin, 12-Step Facilitation with Relapse Prevention and Contingency Management
Clinical Study IdentifierNCT04793685
SponsorYale University
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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)
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