Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia

NCT02153788 | Completed Phase 4 Results

• 1 other identifier: Pro00018356
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

Insomnia; HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  Randomization to final study visit, approximately 12 weeks

Secondary Outcomes (6)

• Mean Change in Self Reported Total Sleep Time

  Randomization to final study visit, approximately 12 weeks

• Mean Change in Self-reported Total Sleep Time

  Randomization to the end of the open label phase, approximately 1 week

• Mean Change in Piper Fatigue Score

  Baseline, week 12

• Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)

  Baseline, week 12

• Mean Change in the Distress Thermometer

  Baseline, week 12

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Temazepam DRUG

Temazepam 15 mg orally at bedtime

temazepam

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Temazepam

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrew Krystal, MD
• Organization: Duke University Medical Center

andrew.krystal@duke.edu

919-681-8742

Study Officials

• Andrew Krystal, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Last Updated: March 10, 2015
• Results First Posted: March 10, 2015

Record last verified: 2015-01