Trial Outcomes & Findings for Opioid and Cannabinoid Pharmacokinetic Interactions (NCT NCT00308555)
NCT ID: NCT00308555
Last Updated: 2016-12-09
Results Overview
Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1, Day 5
Results posted on
2016-12-09
Participant Flow
315 participants were screened, via phone and e-mail, between January 2007 and February 2009. 24 subjects were enrolled, 13 taking morphine and 11 taking oxycodone.
Participant milestones
| Measure |
MS Contin
Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
|
Oxycontin
Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
MS Contin
Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
|
Oxycontin
Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Opioid and Cannabinoid Pharmacokinetic Interactions
Baseline characteristics by cohort
| Measure |
MS Contin
n=13 Participants
Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain
|
Oxycontin
n=11 Participants
Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Mean opioid dose, twice daily
|
62 mg
n=5 Participants
|
53 mg
n=7 Participants
|
58 mg
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 5Population: The number was determined by the number of participants completing both Day 1 and Day 5 procedures.
Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.
Outcome measures
| Measure |
MS Contin
n=10 Participants
Participants on morphine treatment
|
Oxycodone
n=11 Participants
Participants on oxycodone treatment
|
|---|---|---|
|
Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use
Time to maximum concentration (Tmax)
|
1.64 Geometric Mean Ratio
Interval -1.01 to 4.3
|
-1.11 Geometric Mean Ratio
Interval -3.66 to 1.43
|
|
Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use
Maximum concentration (Cmax)
|
0.9 Geometric Mean Ratio
Interval 0.85 to 0.95
|
0.99 Geometric Mean Ratio
Interval 0.89 to 1.1
|
|
Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use
Area under plasma concentration-time curve (AUC)
|
0.95 Geometric Mean Ratio
Interval 0.84 to 1.05
|
0.94 Geometric Mean Ratio
Interval 0.84 to 1.04
|
Adverse Events
MS Contin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxycontin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Donald I. Abrams
UCSF/San Francisco General Hospital
Phone: 415-476-4082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place