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Sponsors and Collaborators: |
University of California, San Francisco National Institute on Drug Abuse (NIDA) |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00308555 |
We are conducting a study to assess whether smoking marijuana affects the safety of prescribed opioids in patients treated for cancer-related pain. This study will assess whether smoking cannabis affects the absorption, distribution, metabolism and excretion of widely used opioid analgesics. We propose to do this by investigating the effects of smoked cannabis in subjects prescribed morphine or oxycodone for cancer-related pain. We will also assess the clinical safety of cannabinoids and these opioids by monitoring the short-term side effects associated with combined therapy.
Condition | Intervention |
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Pain Neoplasms |
Drug: Cannabis |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Opioid and Cannabinoid Pharmacokinetic Interactions: A Pilot Study |
Estimated Enrollment: | 24 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | August 2008 |
Chronic pain conditions remain problematic, especially in patients with cancer. Although opioids are effective analgesics, dose-limiting side effects in the form of sedation, nausea and vomiting, and fear of dependence often limit their use at higher – and possibly more effective – doses. Of particular interest, however, is the potential for greater than additive analgesic effect of cannabinoids and opioids in combination that would allow for opioid analgesic effect to be achieved at lower dosages than are necessary alone, which could overcome problems with both tolerance and side effects for both drug classes. Unfortunately, safety data on the combination in humans does not exist at this time and needs to be obtained. As increasing numbers of patients with cancer may turn to cannabis to augment the effects of their opioid analgesics, data on potential pharmacokinetic interactions and clinical safety of the combinations should be evaluated in a controlled clinical research setting.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory parameters documented within 45 days prior to study entry:
Exclusion Criteria:
Contact: Paul Couey | 415-476-9554 ext 315 | pcouey@php.ucsf.edu |
United States, California | |
Community Consortium | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Paul Couey 415-476-9554 ext 315 pcouey@php.ucsf.edu | |
Principal Investigator: Donald I Abrams, MD |
Principal Investigator: | Donald I Abrams, M.D. | University of California, San Francisco |
Study ID Numbers: | CC # 064, 1 R21 DA 020831-01 |
Study First Received: | March 27, 2006 |
Last Updated: | January 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00308555 |
Health Authority: | United States: Food and Drug Administration |
Cancer pain Cannabis Morphine |
Oxycodone Marijuana Cancer-related pain |
Morphine Oxycodone Pain Marijuana Abuse |
Neoplasms |