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Combined Behavioral/Pharmacological Therapy for Insomnia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), May 2005
First Received: September 3, 2002   Last Updated: November 17, 2005   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00044629
  Purpose

This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.


Condition Intervention
Sleep Initiation and Maintenance Disorders
Behavioral: Cognitive-Behavioral Therapy for Insomnia
Drug: zolpidem tartrate (Ambien)

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Zolpidem
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Combined Behavioral/Pharmacological Therapy for Insomnia

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 144
Study Start Date: September 2001
Estimated Study Completion Date: August 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044629

Locations
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.            
Sponsors and Collaborators
  More Information

No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):
Sleep Deprivation
Insomnia
Sleep Disorders

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009