Trial Outcomes & Findings for Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea (NCT NCT01755091)
NCT ID: NCT01755091
Last Updated: 2021-07-29
Results Overview
Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2021-07-29
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
27
|
|
Overall Study
COMPLETED
|
17
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
7
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
Baseline Characteristics
Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=26 Participants
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
n=22 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=27 Participants
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
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Body Mass Index
|
33.39 kg/m^2
STANDARD_DEVIATION 6.33 • n=99 Participants
|
33.19 kg/m^2
STANDARD_DEVIATION 5.09 • n=107 Participants
|
33.45 kg/m^2
STANDARD_DEVIATION 4.85 • n=206 Participants
|
33.35 kg/m^2
STANDARD_DEVIATION 6.33 • n=7 Participants
|
|
Apnea/Hypopnea Index
|
23.72 events/hour
STANDARD_DEVIATION 9.47 • n=99 Participants
|
27.54 events/hour
STANDARD_DEVIATION 12.57 • n=107 Participants
|
26.04 events/hour
STANDARD_DEVIATION 11.92 • n=206 Participants
|
25.67 events/hour
STANDARD_DEVIATION 11.29 • n=7 Participants
|
|
Minimum Arterial Oxygen Saturation
|
79.58 %
STANDARD_DEVIATION 9.62 • n=99 Participants
|
79.82 %
STANDARD_DEVIATION 6.83 • n=107 Participants
|
79.96 %
STANDARD_DEVIATION 6.93 • n=206 Participants
|
79.79 %
STANDARD_DEVIATION 7.84 • n=7 Participants
|
|
Sleep Efficiency
|
75.51 %
STANDARD_DEVIATION 12.50 • n=99 Participants
|
80.52 %
STANDARD_DEVIATION 11.11 • n=107 Participants
|
82.74 %
STANDARD_DEVIATION 12.22 • n=206 Participants
|
79.58 %
STANDARD_DEVIATION 12.25 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Analysis performed including all participants who completed the full 6-weeks of treatment.
Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)
Outcome measures
| Measure |
Sugar Pill
n=17 Participants
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
n=19 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=20 Participants
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
|
|---|---|---|---|
|
Change in Apnea/Hypopnea Index (AHI)
|
7.99 events/hour
Standard Deviation 13.16
|
-1.71 events/hour
Standard Deviation 11.74
|
-5.21 events/hour
Standard Deviation 9.52
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Data are missing for 2 participants randomized to receive Placebo treatment; due to technical error in not completing this instrument.
Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales.
Outcome measures
| Measure |
Sugar Pill
n=15 Participants
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
n=19 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=20 Participants
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
|
|---|---|---|---|
|
Change in Epworth Sleepiness Scale (ESS)
|
-1.47 units on a scale
Standard Deviation 3.29
|
-.26 units on a scale
Standard Deviation 2.94
|
-4.00 units on a scale
Standard Deviation 5.13
|
PRIMARY outcome
Timeframe: Baseline and Week 6Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time.
Outcome measures
| Measure |
Sugar Pill
n=17 Participants
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
n=19 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=20 Participants
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
|
|---|---|---|---|
|
Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)
|
-2.50 minutes
Standard Deviation 13.09
|
-3.70 minutes
Standard Deviation 9.73
|
1.40 minutes
Standard Deviation 11.71
|
SECONDARY outcome
Timeframe: Week 6Population: Data are missing for one participant randomized to receive Placebo treatment due to technical error in not collecting the instrument.
The TSQM measures a person's satisfaction with treatment based on a 7-point scale ranging from "Extremely Dissatisfied" to "Extremely Satisfied" in response to the question, "Taking all things into account, how satisfied or dissatisfied are you with this medication?".
Outcome measures
| Measure |
Sugar Pill
n=16 Participants
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
n=19 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=20 Participants
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
|
|---|---|---|---|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Somewhat Satisfied
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Extremely Dissatisfied
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Very Dissatisfied
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Dissatisfied
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Satisfied
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Very Satisfied
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Extremely Satisfied
|
1 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeksAEs will be evaluated and tracked throughout subject participation (up to 8 weeks)
Outcome measures
| Measure |
Sugar Pill
n=26 Participants
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
n=22 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=27 Participants
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
|
|---|---|---|---|
|
Adverse Events (AEs)
|
3.4 Number of adverse events per participant
Standard Deviation 2.9
|
2.8 Number of adverse events per participant
Standard Deviation 3.6
|
5.8 Number of adverse events per participant
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 6 weeksChange in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment)
Outcome measures
| Measure |
Sugar Pill
n=17 Participants
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
n=19 Participants
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=20 Participants
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
|
|---|---|---|---|
|
Change in Desaturation Time (DT)
|
1.21 minutes
Standard Deviation 3.46
|
-0.19 minutes
Standard Deviation 2.78
|
-0.17 minutes
Standard Deviation 6.68
|
Adverse Events
Sugar Pill
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
2.5 mg/Day
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
10 mg/Day
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugar Pill
n=26 participants at risk
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
n=22 participants at risk
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=27 participants at risk
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
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Cycling injury
|
3.8%
1/26 • Number of events 1
|
0.00%
0/22
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26
|
4.5%
1/22 • Number of events 1
|
0.00%
0/27
|
Other adverse events
| Measure |
Sugar Pill
n=26 participants at risk
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
n=22 participants at risk
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Dronabinol
|
10 mg/Day
n=27 participants at risk
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
|
|---|---|---|---|
|
Nervous system disorders
Sleepy
|
0.00%
0/26
|
0.00%
0/22
|
63.0%
17/27 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1
|
13.6%
3/22 • Number of events 3
|
14.8%
4/27 • Number of events 4
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Number of events 4
|
13.6%
3/22 • Number of events 3
|
48.1%
13/27 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1
|
22.7%
5/22 • Number of events 5
|
33.3%
9/27 • Number of events 9
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3
|
4.5%
1/22 • Number of events 1
|
25.9%
7/27 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/26
|
0.00%
0/22
|
11.1%
3/27 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
3.8%
1/26 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Euphoria
|
0.00%
0/26
|
4.5%
1/22 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place