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Study of the Medication Prazosin for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762710
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
VA Puget Sound Health Care System
University of Washington
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcoholism
Interventions Drug: Prazosin medication
Drug: Placebo medication
Enrollment 92
Recruitment Details Recruitment began in January 2008 and ended June 2014. Six hundred and one people responding to flyers and newspaper advertisements and contacted the study, 151 provided informed consent, and 19 women and 73 men (N = 92) were randomized. Both civilian and veteran participants were seen in an outpatient VA clinic.
Pre-assignment Details

Of the 151 consented into the study, 59 did not go onto be randomized because of the following:

Declined after screen (N=11) (includes missing baseline/first medication appointment) Ineligible at screen (N=48)

  • PTSD (N=11)
  • Acute illness (N=7)
  • Drug dependence (N=4)
  • Drinking inclusion not met (N=20)
  • Other (N=6)
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

Prazosin medication

Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Placebo medication

Placebo medication: Form: Placebo will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Period Title: Overall Study
Started 48 44
Completed 27 29
Not Completed 21 15
Arm/Group Title Prazosin Placebo Total
Hide Arm/Group Description

Prazosin medication

Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Placebo medication

Placebo medication: Form: Placebo will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Total of all reporting groups
Overall Number of Baseline Participants 48 44 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 44 participants 92 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
 100.0%
44
 100.0%
92
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 44 participants 92 participants
47.3  (9.8) 49.1  (9.5) 48.1  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 44 participants 92 participants
Female
11
  22.9%
8
  18.2%
19
  20.7%
Male
37
  77.1%
36
  81.8%
73
  79.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 48 participants 44 participants 92 participants
48
 100.0%
44
 100.0%
92
 100.0%
1.Primary Outcome
Title Alcohol Consumption
Hide Description At the baseline and final medication visits, the Form 90 (19) was used to assess alcohol and drug use for the preceding 90-day period
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Providing baseline and last week of medication information for all participants that completed the titration period (40 in each group).
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

Prazosin medication

Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Placebo medication

Placebo medication: Form: Placebo will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: percentage of days heavy drinking
Baseline % Days Heavy Drinking 71.8  (29.1) 66.5  (26.0)
Final medication week % Days Heavy Drinking 11.4  (22.8) 22.6  (34.1)
Time Frame Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study.
Adverse Event Reporting Description Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.
 
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

Prazosin medication

Prazosin medication: Form: Prazosin will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

Placebo medication

Placebo medication: Form: Placebo will be taken orally, in the form of pills.

Dosing: 9 AM, 3 PM, 9 PM

Days 1-2: 0 mg, 0 mg, 1 mg

Days 3-4: 1 mg, 1 mg, 1 mg

Days 5-7: 2 mg, 2 mg, 2 mg

Day 8-10: 2 mg, 2 mg, 6 mg

Day 11-14: 4 mg, 4 mg, 6 mg

Day 15-84: 4 mg, 4 mg, 8 mg

All-Cause Mortality
Prazosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)      1/44 (2.27%)    
Hide Serious Adverse Events
Prazosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/48 (6.25%)      2/44 (4.55%)    
Gastrointestinal disorders     
medical hospitalization  [1]  0/48 (0.00%)  0 1/44 (2.27%)  1
Infections and infestations     
Medical hospitalization  [2]  1/48 (2.08%)  1 0/44 (0.00%)  0
Psychiatric disorders     
Death * [3]  0/48 (0.00%)  0 1/44 (2.27%)  1
inpatient alcohol detoxification  [4]  2/48 (4.17%)  2 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
placebo participant hospitalized for acute pancreatitis
[2]
prazosin participant admitted to hospital for infected wisdom tooth
*
Indicates events were collected by non-systematic assessment
[3]
Placebo participant committed suicide.
[4]
two prazosin participants were hospitalized for acute alcohol withdrawal
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prazosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/48 (58.33%)      15/44 (34.09%)    
General disorders     
Drowsiness   28/48 (58.33%)  15/44 (34.09%) 
Indicates events were collected by systematic assessment
Lack of knowledge of optimal dosing for prazosin and medication adherence (medication adherence was suboptimal).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tracy Simpson
Organization: VA Puget Sound
Phone: (206) 277-3337
EMail: Tracy.Simpson@va.gov
Layout table for additonal information
Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT00762710    
Other Study ID Numbers: 1R01AA017184-01 ( U.S. NIH Grant/Contract )
5R01AA017184-05 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: October 18, 2018
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020