The Treatment of Insomnia in Patients With HIV Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00465972
First received: April 25, 2007
Last updated: July 26, 2013
Last verified: May 2013
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Insomnia
Interventions: Drug: Doxepin
Drug: Temazepam
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
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
  Description
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  
NOT COMPLETED     2     1  
Withdrawal by Subject                 2                 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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  18     23     41  
Age  
[units: Years]
Mean ± Standard Deviation
  48.46  ± 5.1     47.8  ± 7.9     48.1  ± 6.6  
Gender  
[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 [2]
[units: Scores on a scale]
Mean ± Standard Deviation
  138  ± 42     114  ± 48     116  ± 45  
[1] Measures the severity of insomnia on 7 items, with a rating of 0 (low severity) to 4 (high severity). Total range for the index is 0-28; with 28 being the most severe.
[2] A 22 item survey measuring level of fatigue. Subjects answer each item on a scale of 1 - 10, with 1 being low fatigue, and 10 being severe fatigue. Total range of overall score is 22-220, with 220 being severe fatigue.



  Outcome Measures
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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
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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: Andrew Krystal, MD, MS, Professor of Psychiatry and Behavioral Sciences
Organization: Duke University School of Medicine
phone: 919-681-8742
e-mail: andrew.krystal@duke.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00465972     History of Changes
Other Study ID Numbers: 8899
Study First Received: April 25, 2007
Results First Received: December 12, 2012
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board