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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| 2 | Active Comparator | Doxepin |
|
| 3 | Active Comparator | Temazepam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxepin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response: Change in Insomnia Severity Rating Scale at 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. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Piper Fatigue Scale at 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. | Baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Krystal, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15784792 | Background | Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. doi: 10.1097/01.psy.0000151771.46127.df. | |
| 22131611 | Derived | Low Y, Preud'homme X, Goforth HW, Omonuwa T, Krystal AD. The association of fatigue with depression and insomnia in HIV-seropositive patients: a pilot study. Sleep. 2011 Dec 1;34(12):1723-6. doi: 10.5665/sleep.1446. |
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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.
Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | One sugar pill taken orally at bedtime for duration of the participant's involvement. |
| FG001 | Temazepam | One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 1 sugar pill taken nightly at bedtime. |
| BG001 | Temazepam | 1 15 mg pill taken nightly at bedtime. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response: Change in Insomnia Severity Rating Scale at 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. | This is the LOCF population | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 1 sugar pill taken nightly at bedtime. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dry mouth | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Krystal, MD, MS, Professor of Psychiatry and Behavioral Sciences | Duke University School of Medicine | 919-681-8742 | andrew.krystal@duke.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D004316 | Doxepin |
| D013693 | Temazepam |
| ID | Term |
|---|---|
| D010082 | Oxepins |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D003990 |
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| Temazepam | Drug | Temazepam capsule 15 mg po nightly x duration of study |
|
| Placebo | Drug | Placebo capsule nightly for duration of study |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index | 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. | Mean | Standard Deviation | Scores on a scale |
|
| Piper Fatigue Scale | 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. | Mean | Standard Deviation | Scores on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Piper Fatigue Scale at 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | Temazepam | 1 15 mg pill taken orally, nightly, at bedtime. | 0 | 23 | 4 | 23 |
| sedation | Nervous system disorders | Non-systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |