Combined Behavioral/Pharmacological Therapy for Insomnia
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ClinicalTrials.gov Identifier: NCT00044629 |
Recruitment Status :
Completed
First Posted : September 5, 2002
Last Update Posted : September 16, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders | Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) Drug: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Combined Behavioral/Pharmacological Therapy for Insomnia |
Study Start Date : | September 2001 |
Study Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
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Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) |
Placebo Comparator: Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
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Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: Placebo |
Active Comparator: Cognitive Behavioral Therapy alone (no drug)
Cognitive Behavioral Therapy alone (no drug)
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Behavioral: Cognitive-Behavioral Therapy for Insomnia |

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- be between 21 and 75 years of age
- have a mean total nocturnal wake time of > 60 min./night
- have a history of insomnia > 6 months
- have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by > 2 hrs. from day to day, or routinely lying in bed awake for periods > 30 min
Exclusion Criteria:
- pregnant women
- the terminally ill
- individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep
- individuals with major psychiatric diagnoses
- persons with hypnotic-dependent insomnia
- subjects on antidepressants or anxiolytics
- subjects with evidence of sleep apnea

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044629
United States, North Carolina | |
Duke Sleep Disorders Center | |
Durham, North Carolina, United States, 27710 |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00044629 |
Other Study ID Numbers: |
Pro00011850 R01MH062119 ( U.S. NIH Grant/Contract ) DSIR 83-ATAS |
First Posted: | September 5, 2002 Key Record Dates |
Last Update Posted: | September 16, 2013 |
Last Verified: | September 2013 |
Sleep Deprivation Insomnia Sleep Disorders |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Zolpidem Sleep Aids, Pharmaceutical |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |