Trial Outcomes & Findings for The Treatment of Insomnia in Patients With HIV Disease (NCT NCT00465972)

Last Updated: 2013-07-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2013-07-30

Participant Flow

Subjects were recruited from an HIV clinic in the Department of Internal Medicine, Duke University Medical Center

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20	24
Overall Study COMPLETED	18	23
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

The Treatment of Insomnia in Patients With HIV Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=18 Participants 1 sugar pill taken nightly at bedtime.	Temazepam n=23 Participants 1 15 mg pill taken nightly at bedtime.	Total n=41 Participants Total of all reporting groups
Age Continuous	48.46 Years STANDARD_DEVIATION 5.1 • n=99 Participants	47.8 Years STANDARD_DEVIATION 7.9 • n=107 Participants	48.1 Years STANDARD_DEVIATION 6.6 • n=206 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	10 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	13 Participants n=107 Participants	23 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	16 Participants n=99 Participants	22 Participants n=107 Participants	38 Participants n=206 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Insomnia Severity Index	17.7 Scores on a scale STANDARD_DEVIATION 4.9 • n=99 Participants	16.6 Scores on a scale STANDARD_DEVIATION 5.1 • n=107 Participants	17.1 Scores on a scale STANDARD_DEVIATION 5.0 • n=206 Participants
Piper Fatigue Scale	138 Scores on a scale STANDARD_DEVIATION 42 • n=99 Participants	114 Scores on a scale STANDARD_DEVIATION 48 • n=107 Participants	116 Scores on a scale STANDARD_DEVIATION 45 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: This is the LOCF population

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.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants 1 sugar pill taken orally at bedtime.	Temazepam n=23 Participants 1 15 mg pill of temazepam taken orally at bedtime.
Response: Change in Insomnia Severity Rating Scale at 3 Months.	0.72 units on a scale Standard Deviation 6.1	-4.01 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants 1 sugar pill taken orally at bedtime.	Temazepam n=23 Participants 1 15 mg pill of temazepam taken orally at bedtime.
Change in Piper Fatigue Scale at 3 Months	12 units on a scale Standard Deviation 6.1	17 units on a scale Standard Deviation 5.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Temazepam

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=18 participants at risk 1 sugar pill taken nightly at bedtime.	Temazepam n=23 participants at risk 1 15 mg pill taken orally, nightly, at bedtime.
Nervous system disorders dry mouth	5.6% 1/18 • Number of events 1	13.0% 3/23 • Number of events 3
Nervous system disorders sedation	5.6% 1/18 • Number of events 1	4.3% 1/23 • Number of events 1

Additional Information

Andrew Krystal, MD, MS, Professor of Psychiatry and Behavioral Sciences

Duke University School of Medicine

Phone: 919-681-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place