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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00044629 |
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
Condition | Intervention |
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Sleep Initiation and Maintenance Disorders |
Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Combined Behavioral/Pharmacological Therapy for Insomnia |
Estimated Enrollment: | 144 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | August 2006 |
Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia.
During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires.
Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires.
After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study.
After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, North Carolina | |
Duke Sleep Disorders Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: William K Wohlgemuth, Ph.D. 919-684-4368 wkw@geri.duke.edu | |
Contact: Victoria Herring 919-681-8392 | |
Principal Investigator: William K Wohlgemuth, Ph.D. | |
Sub-Investigator: Andrew Krystal, M.D. | |
Sub-Investigator: Jack D Edinger, Ph.D. |
Study ID Numbers: | R01 MH62119, DSIR 83-ATAS |
Study First Received: | September 3, 2002 |
Last Updated: | November 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00044629 History of Changes |
Health Authority: | United States: Federal Government |
Sleep Deprivation Insomnia Sleep Disorders |
Zolpidem Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Mental Disorders GABA Agonists Hypnotics and Sedatives |
Central Nervous System Depressants Dyssomnias Sleep Disorders Sleep Deprivation Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Zolpidem Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Dyssomnias Sleep Disorders |
Pharmacologic Actions Sleep Disorders, Intrinsic Mental Disorders Therapeutic Uses GABA Agonists Hypnotics and Sedatives GABA Agents Central Nervous System Agents |