Clinical Trials Logo
  1. Home
  2. Insomnia
  3. NCT02153788

Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia

Insomnia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02153788
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 4
Start date September 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A