The Treatment of Insomnia in Patients With HIV Disease
|Study Design:||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
|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|
|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.
|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
|Withdrawal by Subject||2||1|
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|
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