Sleep Initiation and Maintenance DisordersPhase 2NCT00044629
Combined Behavioral/Pharmacological Therapy for Insomnia
A Phase 2 study testing Cognitive-Behavioral Therapy for Insomnia and zolpidem tartrate (Ambien) in people with Sleep Initiation and Maintenance Disorders, run by Duke University at 1 site in United States.
Trial summary
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Cognitive-Behavioral Therapy for Insomnia and zolpidem tartrate (Ambien)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sleep Disorders Center
Durham, North Carolina, 27710
About this study
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
Read the 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.
- Being tested
- Cognitive-Behavioral Therapy for Insomnia, zolpidem tartrate (Ambien), Placebo
- Keywords
- Sleep Deprivation, Insomnia, Sleep Disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for InsomniaBehavioural
zolpidem tartrate (Ambien)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy and Ambien | Experimental | Cognitive Behavioral Therapy and Ambien Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia; Drug: zolpidem tartrate (Ambien) |
| Cognitive Behavioral Therapy and Placebo | Placebo comparator | Cognitive Behavioral Therapy and Placebo Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia; Drug: Placebo |
| Cognitive Behavioral Therapy alone (no drug) | Active comparator | Cognitive Behavioral Therapy alone (no drug) Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2002 (estimated)
- Study startSep 2001
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044629
- Sponsor's protocol ID
- Pro00011850
- Other IDs
- R01MH062119, DSIR 83-ATAS
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2002
- Last updated
- 16 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Behavioral/Pharmacological Therapy for Insomnia
- ClinicalTrials.gov ID
- NCT00044629
- Acronym / sponsor ID
- Pro00011850
- Keywords
- Sleep Deprivation, Insomnia, Sleep Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Study completion
- Aug 2006
- First posted
- 5 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy and Ambien | Experimental | Behavioral: Cognitive-Behavioral Therapy for Insomnia, Drug: zolpidem tartrate (Ambien)Cognitive Behavioral Therapy and Ambien |
| Cognitive Behavioral Therapy and Placebo | Placebo comparator | Behavioral: Cognitive-Behavioral Therapy for Insomnia, Drug: PlaceboCognitive Behavioral Therapy and Placebo |
| Cognitive Behavioral Therapy alone (no drug) | Active comparator | Behavioral: Cognitive-Behavioral Therapy for InsomniaCognitive Behavioral Therapy alone (no drug) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Behavioural | Cognitive Behavioral Therapy alone (no drug), Cognitive Behavioral Therapy and Ambien, Cognitive Behavioral Therapy and Placebo |
| zolpidem tartrate (Ambien) | Drug | Cognitive Behavioral Therapy and Ambien |
| Placebo | Drug | Cognitive Behavioral Therapy and Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive-Behavioral Therapy for Insomnia and zolpidem tartrate (Ambien) in people with Sleep Initiation and Maintenance Disorders, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.