A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- HIV Infections
- Sponsor
- Duke University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Response: Change in Insomnia Severity Rating Scale at 3 Months.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
Detailed Description
Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population. Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV Seropositive
- •Stable HIV Disease
Exclusion Criteria
- •Other psychiatric illnesses
- •Unstable HIV disease
Arms & Interventions
Placebo
Placebo
Intervention: Placebo
2
Doxepin
Intervention: Doxepin
3
Temazepam
Intervention: Temazepam
Outcomes
Primary Outcomes
Response: Change in Insomnia Severity Rating Scale at 3 Months.
Time Frame: Baseline and 3 months
Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.
Secondary Outcomes
- Change in Piper Fatigue Scale at 3 Months(Baseline and 3 months)