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The Treatment of Insomnia in Patients With HIV Disease
This study has been completed.
Sponsor:
Duke University
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Insomnia | Drug: Doxepin Drug: Temazepam Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia. |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- 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 Outcome Measures:
- Change in Piper Fatigue Scale at 3 Months [ Time Frame: Baseline and 3 months ]A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.
| Enrollment: | 44 |
| Study Start Date: | March 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo capsule nightly for duration of study
|
|
Active Comparator: 2
Doxepin
|
Drug: Doxepin
Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length
|
|
Active Comparator: 3
Temazepam
|
Drug: Temazepam
Temazepam capsule 15 mg po nightly x duration of study
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Insomnia
- HIV Seropositive
- Stable HIV Disease
Exclusion Criteria:
- Other psychiatric illnesses
- Unstable HIV disease
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465972
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465972
Locations
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Andrew D Krystal, MD | Duke University |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Duke University:
|
HIV Insomnia Cytokines Adherence |
Additional relevant MeSH terms:
|
HIV Infections Sleep Initiation and Maintenance Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |
Doxepin Temazepam Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents GABA Modulators |
ClinicalTrials.gov processed this record on September 18, 2017