Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).

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. Identifier: NCT00744055
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : January 18, 2016
Last Update Posted : April 18, 2016
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Stress Disorders, Post-Traumatic
Interventions: Drug: Prazosin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Randomization was conducted by the pharmacy using a 1:1 randomization in blocks of 4 and stratified by site, gender.

Completers were defined as subjects for whom we had complete data at the end of the treatment period (week 12) whether they remained on medication or not.

Reporting Groups

prazosin (16mg/day)

Prazosin: prazosin (16mg/day) 2 times a day


Placebo in identical looking capsule blister packs

Placebo: Placebo

Participant Flow:   Overall Study
    Prazosin   Placebo
STARTED   50   46 
COMPLETED   43   32 
Withdrawal by Subject                6                9 
Lack of Efficacy                0                1 
Physician Decision                0                2 
Protocol Violation                1                1 
Lost to Follow-up                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups
Prazosin men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
Placebo men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
Total Total of all reporting groups

Baseline Measures
   Prazosin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   46   96 
[Units: Years]
Mean (Standard Deviation)
 44.5  (13.2)   43.40  (12.95)   43.96  (12.96) 
[Units: Participants]
Female   4   2   6 
Male   46   44   90 
Race/Ethnicity, Customized 
[Units: Participants]
Caucasian   40   38   78 
Non-Caucasian   10   8   18 
PTSD Symptoms [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 71.86  (20.32)   75.86  (14.44)   73.7  (17.86) 
Average Drinks Per Drinking Day 
[Units: Drinks per day]
Mean (Standard Deviation)
 17.33  (10.73)   21.90  (13.24)   19.53  (8.21) 

  Outcome Measures

1.  Primary:   Number of Drinking Days   [ Time Frame: 12 weeks ]

2.  Primary:   Clinician-Administered PTSD Scale   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Elizabeth Ralevski
Organization: Yale University School Of Medicine Department of Psychiatry
phone: 2039325711 ext 4282

Responsible Party: Yale University Identifier: NCT00744055     History of Changes
Other Study ID Numbers: 00032
First Submitted: August 28, 2008
First Posted: August 29, 2008
Results First Submitted: October 27, 2015
Results First Posted: January 18, 2016
Last Update Posted: April 18, 2016