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Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Primary Purpose

Alcohol Withdrawal

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prazosin
12-Step Facilitation with Relapse Prevention and Contingency Management
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Withdrawal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • The Yale Stress Center: Yale UniversityRecruiting
  • The Yale Stress Center: Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Drug

Placebo Drug

Arm Description

Prazosin (16mg/day) versus Placebo comparator, administered in t.i.d schedule, in capsules, over a 12 week period, with 2 weeks titration in weeks 1-2 and a 5-day taper in week 12.

Placebo for 12 weeks.

Outcomes

Primary Outcome Measures

Percent of Subjects with no Heavy Drinking Days
Prazosin versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.

Secondary Outcome Measures

Percent Heavy Drinking Days
Percent of overall days with heavy drinking days (defined by 5 or more drinks per day in men and 4 or more drinks/day in women).
Percent Any Drinking Days
Percent of any drinking days over a 12 week period.
Average Drinks per Day
The average number of drinks consumed per day assessed weekly over the treatment period.

Full Information

First Posted
March 3, 2021
Last Updated
January 10, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04793685
Brief Title
Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
Official Title
Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Drug
Arm Type
Experimental
Arm Description
Prazosin (16mg/day) versus Placebo comparator, administered in t.i.d schedule, in capsules, over a 12 week period, with 2 weeks titration in weeks 1-2 and a 5-day taper in week 12.
Arm Title
Placebo Drug
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Prazosin
Other Intervention Name(s)
Minipress
Intervention Description
Prazosin (16mg/day) versus Placebo comparator, with a 2 week titration period, 9 weeks at full dose and a 5-day taper in week 12.
Intervention Type
Behavioral
Intervention Name(s)
12-Step Facilitation with Relapse Prevention and Contingency Management
Intervention Description
12-Step Facilitation and relapse prevention weekly support and Contingency Management with vouchers for each weekly appointment to support treatment attendance for all subjects.
Primary Outcome Measure Information:
Title
Percent of Subjects with no Heavy Drinking Days
Description
Prazosin versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Percent Heavy Drinking Days
Description
Percent of overall days with heavy drinking days (defined by 5 or more drinks per day in men and 4 or more drinks/day in women).
Time Frame
up to 12 weeks
Title
Percent Any Drinking Days
Description
Percent of any drinking days over a 12 week period.
Time Frame
up to 12 weeks
Title
Average Drinks per Day
Description
The average number of drinks consumed per day assessed weekly over the treatment period.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAJITA SINHA, PhD
Phone
12038592840
Email
rajita.sinha@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Hart, MA
Phone
203-641-4922
Email
rachel.hart@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Fiellin, MD
Organizational Affiliation
Yale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gretchen Hermes, MD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
The Yale Stress Center: Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Hart, MS
Phone
203-737-4791
Email
rachel.hart@yale.edu
First Name & Middle Initial & Last Name & Degree
RAJITA SINHA
Phone
2037375805
Email
rajita.sinha@yale.edu
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD
Facility Name
The Yale Stress Center: Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Hart, MS
Phone
203-737-4791
Email
rachel.hart@yale.edu
First Name & Middle Initial & Last Name & Degree
RAJITA SINHA, PHD
Phone
12037375805
Email
rajita.sinha@yale.edu
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be uploaded to NIAAA data archive (NIAAA-DA housed within the NIMH Data archive (NDa). as per NIH-NIAAA guidelines.
IPD Sharing Time Frame
Baseline data will be uploaded twice yearly. clinical trial outcome data will be shared after study completion and breaking the blind and completion of final analysis of the main study outcomes.
IPD Sharing Access Criteria
Access will be provided following the NIH-NIAAA guidelines available at https://grants.nih.gov/grants/guide/notice-files/NOT-AA-19-020.html at the URL below.
IPD Sharing URL
http://nda.nih.gov/contribute/contribute-data.html
Citations:
PubMed Identifier
33207935
Citation
Sinha R, Wemm S, Fogelman N, Milivojevic V, Morgan PM, Angarita GA, Hermes G, Fox HC. Moderation of Prazosin's Efficacy by Alcohol Withdrawal Symptoms. Am J Psychiatry. 2021 May 1;178(5):447-458. doi: 10.1176/appi.ajp.2020.20050609. Epub 2020 Nov 19.
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Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

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