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Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jed E Black, Stanford University
ClinicalTrials.gov Identifier:
NCT00383643
First received: September 29, 2006
Last updated: April 26, 2017
Last verified: April 2017
Results First Received: February 15, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Sleep Initiation and Maintenance Disorders
Interventions: Drug: zolpidem tartrate
Drug: sodium oxybate
Drug: Matching Placebos

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited through local newspaper ads and from the Stanford Sleep Disorders Clinic. A general description of the study was provided. Preliminary screening was conducted by telephone. Interested and qualified persons were scheduled for an in-person screening visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zolpidem Tartrate Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Placebo Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Sodium Oxybate Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.

Participant Flow:   Overall Study
    Zolpidem Tartrate   Placebo   Sodium Oxybate
STARTED   18   16   14 
COMPLETED   17   15   13 
NOT COMPLETED   1   1   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zolpidem Tartrate Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Placebo Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Sodium Oxybate Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Total Total of all reporting groups

Baseline Measures
   Zolpidem Tartrate   Placebo   Sodium Oxybate   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   16   14   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (9.6)   56.4  (10.4)   49.6  (16.3)   53.2  (12.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      12  66.7%      11  68.8%      9  64.3%      32  66.7% 
Male      6  33.3%      5  31.3%      5  35.7%      16  33.3% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Ethnic Minorities   3   5   3   11 
Region of Enrollment 
[Units: Participants]
       
United States   18   16   14   48 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Assessment of Clinical Global Impression-change.   [ Time Frame: Baseline to week 12 ]

2.  Primary:   Assessment of Insomnia Severity Index   [ Time Frame: 12 weeks ]

3.  Primary:   Assessment of Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: One month ]

4.  Primary:   Assessment of Fatigue   [ Time Frame: One month ]

5.  Primary:   Assessment of Sleepiness   [ Time Frame: One month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Insufficient power for most parameters was a planned limitation of the study. Replication with a larger sample is needed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jed Black
Organization: Stanford University School of Medicine, Dept of Psychiatry
phone: 650 736 4559
e-mail: jedblack@stanford.edu



Responsible Party: Jed E Black, Stanford University
ClinicalTrials.gov Identifier: NCT00383643     History of Changes
Other Study ID Numbers: 95900
Study First Received: September 29, 2006
Results First Received: February 15, 2017
Last Updated: April 26, 2017