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Trial record 36 of 2095 for:    Symptoms | Parasomnias

Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD (PACT)

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ClinicalTrials.gov Identifier: NCT00532493
Recruitment Status : Completed
First Posted : September 20, 2007
Results First Posted : June 18, 2014
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: PTSD
Sleep Disorders
Interventions: Drug: prazosin
Other: 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
No text entered.

Reporting Groups
  Description
Prazosin Group

Subjects randomized to this arm will be on prazosin.

prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.

Placebo Group

Subjects randomized to this arm will be on placebo.

placebo: "sugar" pill


Participant Flow:   Overall Study
    Prazosin Group   Placebo Group
STARTED   152   152 
COMPLETED   122   123 
NOT COMPLETED   30   29 
Death                1                1 
Lost to Follow-up                10                7 
Withdrawal by Subject                7                9 
Physician Decision                1                6 
Adverse Event                6                5 
Protocol Deviation                1                0 
Subject Moved Away                3                1 
Contraindicative Medication                1                0 



  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.
PTSD clinicians ascertain interest and eligibility among their patients with nightmare. Informed consent obtained; screening assessments to determine eligibility

Reporting Groups
  Description
Prazosin Group

Subjects randomized to this arm will be on prazosin.

prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.

Placebo Group

Subjects randomized to this arm will be on placebo.

placebo: "sugar" pill

Total Total of all reporting groups

Baseline Measures
   Prazosin Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   152   304 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (13.8)   51.4  (13.8)   51.8  (13.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6   3.9%      1   0.7%      7   2.3% 
Male      146  96.1%      151  99.3%      297  97.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   1.3%      1   0.7%      3   1.0% 
Asian      3   2.0%      1   0.7%      4   1.3% 
Native Hawaiian or Other Pacific Islander      1   0.7%      0   0.0%      1   0.3% 
Black or African American      38  25.0%      37  24.3%      75  24.7% 
White      91  59.9%      101  66.4%      192  63.2% 
More than one race      9   5.9%      4   2.6%      13   4.3% 
Unknown or Not Reported      8   5.3%      8   5.3%      16   5.3% 
Highest Educational Level 
[Units: Participants]
     
Grade School or Less   0   0   0 
Some High School   5   5   10 
High School/GED   35   29   64 
Some College/Ass.Degree/Tech.School   79   77   156 
College Graduate   22   25   47 
Post Graduate/Professional Degree   7   13   20 
Other   2   1   3 
Did Not Answer   2   2   4 
Marital Status 
[Units: Participants]
     
Single   17   20   37 
Married   82   89   171 
Living Together in a Relationship   3   4   7 
Separated   6   6   12 
Divorced   39   27   66 
Widowed   3   4   7 
Did Not Answer   2   2   4 
Major Depression 
[Units: Participants]
     
Yes   51   64   115 
No   101   88   189 
Maintained on any Antidepressant 
[Units: Participants]
     
Yes   119   117   236 
No   33   35   68 
Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI) 
[Units: Participants]
     
Yes   113   113   226 
No   39   39   78 


  Outcome Measures

1.  Primary:   CAPS Recurrent Distressing Dreams Item   [ Time Frame: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported. ]

2.  Primary:   Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported. ]

3.  Primary:   Clinical Global Impression of Change (CGIC)   [ Time Frame: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported. ]

4.  Secondary:   Pittsburgh Sleep Quality Index   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]

5.  Secondary:   CAPS Recurrent Distressing Dreams Item   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo. ]

6.  Secondary:   Clinical Global Impression of Change   [ Time Frame: This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]

7.  Secondary:   Total CAPS Score   [ Time Frame: The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination). ]

8.  Secondary:   PTSD Checklist-Military Version (PCL-M) Score   [ Time Frame: This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity. ]

9.  Secondary:   Patient Health Questionnaire-9 (PHQ9)   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]

10.  Secondary:   SF-12 Physical Standardized Score (SF-12 PCS)   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]

11.  Secondary:   SF-12 Mental Standardized Score (SF-12 MCS)   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]

12.  Secondary:   Quality of Life Inventory (QOLI)   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]

13.  Secondary:   Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)   [ Time Frame: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination). ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Murray Rasknd
Organization: VA Puget Sound Health Care System
phone: (206) 764-2702
e-mail: Murray.Raskind@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00532493     History of Changes
Other Study ID Numbers: 563
First Submitted: September 18, 2007
First Posted: September 20, 2007
Results First Submitted: April 2, 2014
Results First Posted: June 18, 2014
Last Update Posted: May 1, 2018