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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00744055
First received: August 28, 2008
Last updated: March 18, 2016
Last verified: March 2016
Results First Received: October 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Stress Disorders, Post-Traumatic
Interventions: Drug: Prazosin
Drug: Placebo

  Participant Flow
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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
  Description
Prazosin

prazosin (16mg/day)

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

Placebo

Placebo in identical looking capsule blister packs

Placebo: Placebo


Participant Flow:   Overall Study
    Prazosin     Placebo  
STARTED     50     46  
COMPLETED     43     32  
NOT COMPLETED     7     14  
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
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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.
Veterans

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  50     46     96  
Age  
[units: years]
Mean (Standard Deviation)
  44.5  (13.2)     43.40  (12.95)     43.96  (12.96)  
Gender  
[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)  
[1]

Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV). The scale consists of 30 questions on a scale from 0-4.

The lowest possible score is 0 and the highest possible score is 120. A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD




  Outcome Measures
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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
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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
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  More Information
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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
e-mail: elizabeth.ralevski@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00744055     History of Changes
Other Study ID Numbers: 00032
Study First Received: August 28, 2008
Results First Received: October 27, 2015
Last Updated: March 18, 2016
Health Authority: United States: Institutional Review Board