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Opioid and Cannabinoid Pharmacokinetic Interactions

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ClinicalTrials.gov Identifier: NCT00308555
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : July 22, 2013
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Cannabis
Enrollment 24
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title MS Contin Oxycontin
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 13 11
Completed 10 11
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             1             0
Physician Decision             2             0
Arm/Group Title MS Contin Oxycontin Total
Hide Arm/Group Description Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain Total of all reporting groups
Overall Number of Baseline Participants 13 11 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
11
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 11 participants 24 participants
42.9  (7.4) 47.1  (11.8) 45.1  (10.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
Female
6
  46.2%
6
  54.5%
12
  50.0%
Male
7
  53.8%
5
  45.5%
12
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 11 participants 24 participants
13 11 24
Mean opioid dose, twice daily   [1] 
Mean (Full Range)
Unit of measure:  Mg
Number Analyzed 13 participants 11 participants 24 participants
62
(10 to 100)
53
(10 to 120)
58
(10 to 120)
[1]
Measure Description: Baseline medication use
1.Primary Outcome
Title Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use
Hide Description Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.
Time Frame Day 1, Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The number was determined by the number of participants completing both Day 1 and Day 5 procedures.
Arm/Group Title MS Contin Oxycodone
Hide Arm/Group Description:
Participants on morphine treatment
Participants on oxycodone treatment
Overall Number of Participants Analyzed 10 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Geometric Mean Ratio
Time to maximum concentration (Tmax)
1.64
(-1.01 to 4.30)
-1.11
(-3.66 to 1.43)
Maximum concentration (Cmax)
0.9
(0.85 to 0.95)
0.99
(0.89 to 1.10)
Area under plasma concentration-time curve (AUC)
0.95
(0.84 to 1.05)
0.94
(0.84 to 1.04)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MS Contin Oxycontin
Hide Arm/Group Description Patients using morphine sulfate (MS Contin) every 12 hours for cancer pain Patients using oxycodone hydrochloride (OxyContin)every 12 hours for cancer pain
All-Cause Mortality
MS Contin Oxycontin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MS Contin Oxycontin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MS Contin Oxycontin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%) 
Small number of participants, powered to detect a 25% change in AUC(12).Further research is needed to determine how cannabis delivery systems other than vapor affect metabolism of opioids and other drugs.
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. Donald I. Abrams
Organization: UCSF/San Francisco General Hospital
Phone: 415-476-4082 ext 444
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00308555     History of Changes
Other Study ID Numbers: CC # 064
1R21DA020831-01 ( U.S. NIH Grant/Contract )
First Submitted: March 27, 2006
First Posted: March 29, 2006
Results First Submitted: May 23, 2013
Results First Posted: July 22, 2013
Last Update Posted: December 9, 2016