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Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea (PACE)

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ClinicalTrials.gov Identifier: NCT01755091
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Northwestern University
University of Chicago
Hektoen Institute for Medical Research
Information provided by (Responsible Party):
David W. Carley, University of Illinois at Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sleep Apnea, Obstructive
Interventions: Drug: Dronabinol
Drug: Placebo (for Dronabinol)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from physician referrals at two academic medical centers as well as from the community based upon print and radio advertising between January 2013 and May 2016. The first participant was enrolled in February 2013 and the last participant was enrolled in April 2016.

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
Sugar Pill

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

2.5 mg/Day

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

10 mg/Day

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol


Participant Flow:   Overall Study
    Sugar Pill   2.5 mg/Day   10 mg/Day
STARTED   26   22   27 
COMPLETED   17   19   20 
NOT COMPLETED   9   3   7 
Withdrawal by Subject                6                1                3 
Adverse Event                1                1                1 
Lost to Follow-up                1                0                1 
Physician Decision                1                1                2 



  Baseline Characteristics

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.
Baseline analysis population includes all participants who were randomized to treatment.

Reporting Groups
  Description
Sugar Pill

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

2.5 mg/Day

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

10 mg/Day

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Total Total of all reporting groups

Baseline Measures
   Sugar Pill   2.5 mg/Day   10 mg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   22   27   75 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      26 100.0%      22 100.0%      27 100.0%      75 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      8  30.8%      6  27.3%      9  33.3%      23  30.7% 
Male      18  69.2%      16  72.7%      18  66.7%      52  69.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      4  15.4%      5  22.7%      1   3.7%      10  13.3% 
Not Hispanic or Latino      22  84.6%      17  77.3%      25  92.6%      64  85.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   3.7%      1   1.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.8%      0   0.0%      2   7.4%      3   4.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   4.5%      0   0.0%      1   1.3% 
Black or African American      15  57.7%      5  22.7%      13  48.1%      33  44.0% 
White      9  34.6%      16  72.7%      12  44.4%      37  49.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   3.8%      0   0.0%      0   0.0%      1   1.3% 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 33.39  (6.33)   33.19  (5.09)   33.45  (4.85)   33.35  (6.33) 
Apnea/Hypopnea Index 
[Units: Events/hour]
Mean (Standard Deviation)
 23.72  (9.47)   27.54  (12.57)   26.04  (11.92)   25.67  (11.29) 
Minimum Arterial Oxygen Saturation 
[Units: %]
Mean (Standard Deviation)
 79.58  (9.62)   79.82  (6.83)   79.96  (6.93)   79.79  (7.84) 
Sleep Efficiency [1] 
[Units: %]
Mean (Standard Deviation)
 75.51  (12.50)   80.52  (11.11)   82.74  (12.22)   79.58  (12.25) 
[1] Sleep Efficiency is calculated as the total time spent asleep divided by the total amount of time spent in bed, multiplied by 100.


  Outcome Measures

1.  Primary:   Change in Apnea/Hypopnea Index (AHI)   [ Time Frame: Baseline and Week 6 ]

2.  Primary:   Change in Epworth Sleepiness Scale (ESS)   [ Time Frame: Baseline and Week 6 ]

3.  Primary:   Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)   [ Time Frame: Baseline and Week 6 ]

4.  Secondary:   Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.   [ Time Frame: Week 6 ]

5.  Secondary:   Adverse Events (AEs)   [ Time Frame: Up to 8 weeks ]

6.  Secondary:   Change in Desaturation Time (DT)   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: David W. Carley, PhD
Organization: University of Illinois at Chicago
phone: 312-996-3827
e-mail: dwcarley@uic.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David W. Carley, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01755091     History of Changes
Other Study ID Numbers: UM1HL112856 2011-06400
UM1HL112856 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2012
First Posted: December 21, 2012
Results First Submitted: October 24, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017