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Trial record 20 of 119 for:    zolpidem AND Hypnotics

The Role of Partial Reinforcement in the Long Term Management of Insomnia (ADER)

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ClinicalTrials.gov Identifier: NCT00662155
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Primary Insomnia
Interventions Drug: Zolpidem
Drug: Placebos
Enrollment 129

Recruitment Details  
Pre-assignment Details 129 individuals were eligible for Phase 1 (2-week assessment period) of the study. 12 participants were withdrawn for non-compliance, 14 dropped out, 28 did not experience a treatment response during Phase 2, and 1 discontinued due to a minor adverse event. In total, 74 participants advanced to phase 3 of the study.
Arm/Group Title QHS-10 IDS-10 PRS-10 QHS-5
Hide Arm/Group Description nightly dosing with 10 mg zolpidem intermittent dosing (3-5 days per week) with 10mg zolpidem nightly "pill use" (50% 10mg zolpidem and 50% placebos) nightly dosing with 5mg zolpidem
Period Title: Overall Study
Started 16 20 20 18
Completed 13 15 13 14
Not Completed 3 5 7 4
Arm/Group Title QHS-10 IDS-10 PRS-10 QHS-5 Total
Hide Arm/Group Description nightly dosing with 10 mg zolpidem intermittent dosing (3-5 days per week) with 10mg zolpidem nightly "pill use" (50% 10mg zolpidem and 50% placebos) nightly dosing with 5mg zolpidem Total of all reporting groups
Overall Number of Baseline Participants 13 15 13 14 55
Hide Baseline Analysis Population Description
Analyses were only conducted among participants who were compliant with their medication regimens during Phase 3.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 13 participants 14 participants 55 participants
39.5  (2.8) 34.0  (2.6) 39.2  (2.8) 34.5  (2.7) 37  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 13 participants 14 participants 55 participants
Female
10
  76.9%
11
  73.3%
11
  84.6%
11
  78.6%
43
  78.2%
Male
3
  23.1%
4
  26.7%
2
  15.4%
3
  21.4%
12
  21.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 15 participants 13 participants 14 participants 55 participants
13 15 13 14 55
1.Primary Outcome
Title Overall Average Sleep Continuity Profile
Hide Description The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep continuity as a function of treatment.
Time Frame 12-week average during Phase 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These were participants that meant compliance criteria and were included in all analyses.
Arm/Group Title QHS-10 IDS-10 PRS-10 QHS-5
Hide Arm/Group Description:
nightly dosing with 10 mg zolpidem
intermittent dosing (3-5 days per week) with 10mg zolpidem
nightly "pill use" (50% 10mg zolpidem and 50% placebos)
nightly dosing with 5mg zolpidem
Overall Number of Participants Analyzed 13 15 13 14
Mean (Standard Error)
Unit of Measure: minutes
Sleep Latency 28.8  (3.4) 33.8  (4.2) 19.1  (3.8) 20.7  (2.0)
Wake After Sleep Onset 21.8  (2.6) 28.4  (5.2) 20.0  (4.3) 11.3  (3.6)
Total Sleep Time 465  (14.4) 426.1  (9.4) 463.6  (12.7) 486.6  (11.1)
2.Primary Outcome
Title Overall Average Sleep Efficiency (%)
Hide Description The standard measure for clinical trials research in insomnia is the sleep diary. This prospective self-report measurement tool provides an assessment of sleep efficiency (total sleep time/time in bed x 100) as a function of treatment.
Time Frame 12-week average during Phase 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These were participants that meant compliance criteria and were included in all analyses.
Arm/Group Title QHS-10 IDS-10 PRS-10 QHS-5
Hide Arm/Group Description:
nightly dosing with 10 mg zolpidem
intermittent dosing (3-5 days per week) with 10mg zolpidem
nightly "pill use" (50% 10mg zolpidem and 50% placebos)
nightly dosing with 5mg zolpidem
Overall Number of Participants Analyzed 13 15 13 14
Mean (Standard Error)
Unit of Measure: percent sleep efficiency
90.1  (0.8) 87.5  (1.6) 92.0  (1.2) 93.8  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QHS-10 IDS-10 PRS-10 QHS-5
Hide Arm/Group Description nightly dosing with 10 mg zolpidem intermittent dosing (3-5 days per week) with 10mg zolpidem nightly "pill use" (50% 10mg zolpidem and 50% placebos) nightly dosing with 5mg zolpidem
All-Cause Mortality
QHS-10 IDS-10 PRS-10 QHS-5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QHS-10 IDS-10 PRS-10 QHS-5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
QHS-10 IDS-10 PRS-10 QHS-5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/18 (0.00%) 
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: Michael Perlis
Organization: University of Pennsylvania
Phone: (215) 746-3577
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00662155     History of Changes
Other Study ID Numbers: RSRB # 14533
1R01AT003332-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 16, 2008
First Posted: April 21, 2008
Results First Submitted: December 7, 2016
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017