The Treatment of Insomnia in Patients With HIV Disease

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00465972
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 3
• Duration (Months): 41
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Insomnia	Drug: Doxepin; Drug: Temazepam; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• 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.
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Response: Change in Insomnia Severity Rating Scale at 3 Months. [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

1. Change in Piper Fatigue Scale at 3 Months [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Insomnia

• HIV Seropositive

• Stable HIV Disease

Exclusion Criteria:

• Other psychiatric illnesses

• Unstable HIV disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Andrew D Krystal, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00465972
• Other Study ID Numbers: 8899
• First Posted: Apr 27, 2007
• Last Update Posted: Jul 30, 2013
• Last Verified: May 1, 2013

• Keywords provided by Duke University: HIV; Insomnia; Cytokines; Adherence
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Doxepin; Temazepam

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center
Pre-assignment Detail	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.

Arm/Group Title	Placebo	Temazepam
Arm/Group Description	One sugar pill taken orally at bedtime for duration of the participant's involvement.	One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.
Period Title: Overall Study
STARTED	20	24
COMPLETED	18	23
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Placebo	Temazepam	Total
Arm/Group Description	1 sugar pill taken nightly at bedtime.	1 15 mg pill taken nightly at bedtime.	Total of all reporting groups
Overall Participants	18	23	41
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48.46 (5.1)	47.8 (7.9)	48.1 (6.6)
Sex: Female, Male (Count of Participants)
Female	8 44.4%	10 43.5%	18 43.9%
Male	10 55.6%	13 56.5%	23 56.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	16 88.9%	22 95.7%	38 92.7%
White	2 11.1%	1 4.3%	3 7.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Insomnia Severity Index (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	17.7 (4.9)	16.6 (5.1)	17.1 (5.0)
Piper Fatigue Scale (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	138 (42)	114 (48)	116 (45)

Outcome Measures

1. Primary Outcome

Title	Response: Change in Insomnia Severity Rating Scale at 3 Months.
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

This is the LOCF population

Arm/Group Title	Placebo	Temazepam
Arm/Group Description	1 sugar pill taken orally at bedtime.	1 15 mg pill of temazepam taken orally at bedtime.
Measure Participants	18	23
Mean (Standard Deviation) [units on a scale]	0.72 (6.1)	-4.01 (5.3)

2. Secondary Outcome

Title	Change in Piper Fatigue Scale at 3 Months
Description	A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Temazepam
Arm/Group Description	1 sugar taken nightly at bedtime.	1 15 mg pill taken nightly at bedtime.
Measure Participants	18	23
Mean (Standard Deviation) [units on a scale]	12 (6.1)	17 (5.3)

Adverse Events

Arm/Group Title	Placebo		Temazepam
Arm/Group Description	1 sugar pill taken nightly at bedtime.		1 15 mg pill taken orally, nightly, at bedtime.
All Cause Mortality
	Placebo		Temazepam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Temazepam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Temazepam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/18 (11.1%)		4/23 (17.4%)
Nervous system disorders
dry mouth	1/18 (5.6%)	1	3/23 (13%)	3
sedation	1/18 (5.6%)	1	1/23 (4.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.