InsomniaPhase 4NCT02153788

Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia

A Phase 4 study testing Temazepam in people with Insomnia, run by Duke University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Insomnia
What is being tested?: Temazepam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: No sites listed yet
Study dates: Sep 2009to Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

males or females age 18-69;
females must utilize an approved form of birth control during the study;
have at least a 3 month history of insomnia as defined in the DSM-IV criteria for primary insomnia;
self report > 60 minutes of wakefulness after initial sleep onset on at least 4 nights of 7 consecutive nights;
self report > 30 minutes of self-reported latency to sleep onset on at least 4 nights of 7 consecutive nights;
Self report < 6.5 hours of total sleep time at least 4 nights of 7 consecutive nights;

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be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures;
agree to participate for the entire study period (a total of approximately 6 months); and
provide documentation of HIV seropositivity and be enrolled in ongoing care for their HIV disease in an infectious disease clinic with their last examination not exceeding 3 months prior to screening date

Who cannot join

Have a clinically significant unstable medical abnormality, or history or presence of significant neurological disorders (including cognitive disorders), or frequent nightly urination, defined as > 2 times per night;
Had a clinically significant illness, as determined by the Investigator, within 30 days of Initial Screening (Visit 1);
Have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
Have a known or exaggerated pharmacological sensitivity or hypersensitivity or intolerance to doxepin HCl, any tricyclic antidepressant or antihistamine, temazepam or any benzodiazepine;
Have a positive urine drug screen for amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids at Initial Screening (Visit 1);
Self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly;

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Have a history of epilepsy or serious head injury;
Have been on current HAART or antiretroviral regimen for less than 1 month;
Have a recent history (within one year) of alcohol or drug abuse, or current evidence of substance dependence or abuse as defined by DSM-IV-TR criteria;
Have used temazepam for any indication within the 30 days prior to Initial Screening (Visit 1);
Have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug (other than the study drug) during the study;
Current use of any of the following medications: antipsychotics, appetite suppressants, systemic corticosteroids, theophylline, respiratory stimulants and decongestants;
The following medications may be discontinued for the purpose of entry into the study provided the medication is taken at bedtime for the indication of sleep. If the indication is other than sleep, the medication cannot be discontinued for the purpose of entry into the study: anxiolytics, antidepressants, anticonvulsants, histamine-1 receptor antagonists (except for loratadine, desloratidine, and fexofenadine), narcotic analgesics, sedative/hypnotics (other than study drug) or OTC sleep aids;
Have symptoms consistent with the diagnosis of any other sleep disorder other than primary insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, restless leg syndrome, etc.);
Have a body mass index (BMI) greater than or equal to 34;
Have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
Self reports intentional napping more than two times per week;
Have a variation in bedtime of more than three hours on five of seven consecutive nights as recorded on the sleep diary;
Have a history of non-adherence to treatment or clinical visit attendance; or,
subjects taking any benzodiazepine within 5 half-lives prior to the study baseline

About this study

Official title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia

The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sure that subjects are responding to the effects of the study drug and not to other factors, like the attention they are receiving. If you decide to take part in this study, you will take 1 capsule of study drug every night approximately 30 minutes before bedtime for approximately 12 weeks.

This study is to test the study drug called temazepam for the treatment of insomnia (trouble sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the treatment of insomnia. However, because this study requires treatment for 12 weeks instead of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be investigational in this study.

Conditions: Insomnia
Being tested: Temazepam, Placebo
Keywords: Insomnia, HIV
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TemazepamDrug
Temazepam 15 mg orally at bedtime
PlaceboDrug

Study groups in NCT02153788
Study group	Role	What they receive
temazepam	Active comparator	After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. Receives: Drug: Temazepam
Placebo	Placebo comparator	After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in the Insomnia Severity Index
Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.
Measured: Randomization to final study visit, approximately 12 weeks

Secondary outcomes (6)

Mean Change in Self Reported Total Sleep Time
Mean change in self reported Total Sleep Time from Randomization to Final Study Visit in the placebo-controlled phase.
Measured: Randomization to final study visit, approximately 12 weeks
Mean Change in Self-reported Total Sleep Time
Mean change in self-reported total sleep time from randomization to the end of the open label phase
Measured: Randomization to the end of the open label phase, approximately 1 week
Mean Change in Piper Fatigue Score
A multidimensional scale for measuring fatigue, whose validity and reliability have been established across many patient populations including cancer patients, HIV, pregnancy, and myocardial infarction. There are 22 questions, in 3 subscales that measure behavioral, affective meaning, sensory and cognitive/mood aspects of fatigue, each scored on an 11-point likhert scale with a score of 0-10, 0 indicating no fatigue and 10 indicating the most severe fatigue. The Piper Fatigue Scale can range from 0 to 220 with higher scores indicating greater fatigue.
Measured: Baseline, week 12
Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.
Measured: Baseline, week 12
Mean Change in the Distress Thermometer
A clinical tool that has been validated widely especially in cancer patients, to detect clinically significant emotional distress. This is a one-item scale that asks participants to rate their distress on scale from 0-100. Lower scores represent less distress and higher scores indicate greater distress.
Measured: Baseline, week 12
Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)
A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.
Measured: Baseline, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Sep 2010

First posted3 Jun 2014 (estimated)
Study startSep 2009
Primary completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02153788
Sponsor's protocol ID: Pro00018356
Status last verified: Jan 2015
First submitted: 30 May 2014
Last updated: 10 Mar 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia
ClinicalTrials.gov ID: NCT02153788
Acronym / sponsor ID: Pro00018356
Conditions: Insomnia
Keywords: Insomnia, HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Sep 2009
Primary completion: Sep 2010 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Posted 10 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
temazepam	Active comparator	Drug: TemazepamAfter screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboAfter screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

males or females age 18-69;
females must utilize an approved form of birth control during the study;
have at least a 3 month history of insomnia as defined in the DSM-IV criteria for primary insomnia;
self report > 60 minutes of wakefulness after initial sleep onset on at least 4 nights of 7 consecutive nights;
self report > 30 minutes of self-reported latency to sleep onset on at least 4 nights of 7 consecutive nights;

Key exclusion criteria (20 listed)

Have a clinically significant unstable medical abnormality, or history or presence of significant neurological disorders (including cognitive disorders), or frequent nightly urination, defined as > 2 times per night;
Had a clinically significant illness, as determined by the Investigator, within 30 days of Initial Screening (Visit 1);
Have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
Have a known or exaggerated pharmacological sensitivity or hypersensitivity or intolerance to doxepin HCl, any tricyclic antidepressant or antihistamine, temazepam or any benzodiazepine;
Have a positive urine drug screen for amphetamines, benzodiazepines, barbiturates, cocaine, opiates, or cannabinoids at Initial Screening (Visit 1);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TemazepamTemazepam 15 mg orally at bedtime	Drug	temazepam
Placebo	Drug	Placebo

Primary outcome

Mean Change in the Insomnia Severity Index
Time frame: Randomization to final study visit, approximately 12 weeks
Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.

6 secondary outcomes

Mean Change in Self Reported Total Sleep Time
Time frame: Randomization to final study visit, approximately 12 weeks
Mean Change in Self-reported Total Sleep Time
Time frame: Randomization to the end of the open label phase, approximately 1 week
Mean Change in Piper Fatigue Score
Time frame: Baseline, week 12
Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
Time frame: Baseline, week 12
Mean Change in the Distress Thermometer
Time frame: Baseline, week 12
Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)
Time frame: Baseline, week 12

Results and safety

Results posted to the registry on 10 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Temazepam	25	23
Placebo	19	18

Primary outcome: Mean Change in the Insomnia Severity Index

Time frame: Randomization to final study visit, approximately 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Temazepam n = 23	Placebo n = 18
Value	-4.01 (5.3)	0.72 (6.1)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Temazepam	0 of 23 (0%)	4 of 23 (17.4%)	Not reported
Placebo	0 of 18 (0%)	2 of 18 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
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RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Krystal, MD principal investigator

Duke University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Temazepam in people with Insomnia, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in the Insomnia Severity Index (time frame: Randomization to final study visit, approximately 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.