The Treatment of Insomnia in Patients With HIV Disease

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: NCT00465972
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Interventions: Drug: Doxepin
Drug: Temazepam
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
Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center

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

We initially planned to have 3 arms: placebo, temazepam, and doxepin. However, based on the rate of recruitment, we limited the study to 2 arms: placebo and temazepam.

Screening was carried out which included medical, and psychiatric, and sleep assessments.

Reporting Groups
Placebo One sugar pill taken orally at bedtime for duration of the participant's involvement.
Temazepam One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.

Participant Flow:   Overall Study
    Placebo   Temazepam
STARTED   20   24 
COMPLETED   18   23 
Withdrawal by Subject                2                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.
No text entered.

Reporting Groups
Placebo 1 sugar pill taken nightly at bedtime.
Temazepam 1 15 mg pill taken nightly at bedtime.
Total Total of all reporting groups

Baseline Measures
   Placebo   Temazepam   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   23   41 
[Units: Years]
Mean (Standard Deviation)
 48.46  (5.1)   47.8  (7.9)   48.1  (6.6) 
[Units: Participants]
Female   8   10   18 
Male   10   13   23 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   16   22   38 
White   2   1   3 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Insomnia Severity Index [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 17.7  (4.9)   16.6  (5.1)   17.1  (5.0) 
Piper Fatigue Scale [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 138  (42)   114  (48)   116  (45) 

  Outcome Measures

1.  Primary:   Response: Change in Insomnia Severity Rating Scale at 3 Months.   [ Time Frame: Baseline and 3 months ]

2.  Secondary:   Change in Piper Fatigue Scale at 3 Months   [ Time Frame: Baseline and 3 months ]

  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: Andrew Krystal, MD, MS, Professor of Psychiatry and Behavioral Sciences
Organization: Duke University School of Medicine
phone: 919-681-8742

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Duke University Identifier: NCT00465972     History of Changes
Other Study ID Numbers: 8899
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: December 12, 2012
Results First Posted: July 30, 2013
Last Update Posted: July 30, 2013