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Opioid and Cannabinoid Pharmacokinetic Interactions: A Pilot Study

18 Years
Not Enrolling
Pain, Neoplasms

Thank you

Trial Information

Opioid and Cannabinoid Pharmacokinetic Interactions: A Pilot Study

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.

Inclusion Criteria:

1. Ongoing analgesic therapy with either oxycodone hydrochloride (OxyContinâ) or
morphine sulfate (MS Continâ) every 12 hours for cancer pain.

2. Eligible subjects will be ³ 18 years of age with a diagnosis of cancer and an
estimated survival of greater than six months.

3. Subjects must be on a stable dose of opioid medication for at least 2 weeks before

4. Current other analgesic medications will be maintained during the study. The subject
must have been on a stable medication regimen for at least 2 weeks.

5. The following laboratory parameters documented within 45 days prior to study entry:

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) £ 5 X upper
limit of normal (ULN)

- Total bilirubin £ 2 X ULN

- Creatinine £ 2.0 mg/dL (177 µmol/L)

6. All men and women in this study must agree to use adequate birth control during this
study. Acceptable barrier birth control methods are a male condom, female condom,
diaphragm, or intra-uterine (IUD).

7. All women of reproductive potential (who have not reached menopause or undergone
hysterectomy, oophorectomy, or tubal ligation) must have a negative urine b-HCG
pregnancy test performed before initiating the protocol-specified medication.

8. Prior history of use of marijuana. Subjects must have smoked marijuana on at least 6
occasions in their lifetime prior to enrollment.

9. Able to understand and follow the instructions of the investigator, including
completing the pain intensity rating scales.

10. Karnofsky Performance Score >60.

11. Able and willing to provide informed consent.

Exclusion Criteria:

1. Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular
conduction abnormalities, or orthostatic mean blood pressure drop greater than 24
mmHg, severe chronic obstructive pulmonary disease.

2. History of renal or hepatic failure.

3. Evidence of hepatic, hematological or renal dysfunction based on judgment of

4. Active substance abuse (e.g., alcohol or injection drugs).

5. Use of smoked marijuana within 30 days of enrollment verified with a urine THC level.

6. Neurologic dysfunction or psychiatric disorder severe enough to interfere with
assessment of pain or sensory systems.

7. Current use of smoked tobacco products or a confirmed cotinine level.

8. Women who are pregnant or breast-feeding may not take part in this study.

9. Unable to read or speak English.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the effects of smoking cannabis on the disposition kinetics of morphine

Outcome 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.

Outcome Time Frame:

Day 1, Day 5

Safety Issue:


Principal Investigator

Donald I Abrams, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:

CC # 064



Start Date:

May 2006

Completion Date:

March 2009

Related Keywords:

  • Pain
  • Neoplasms
  • Cancer pain
  • Cannabis
  • Morphine
  • Oxycodone
  • Marijuana
  • Cancer-related pain
  • Neoplasms



Community ConsortiumSan Francisco, California  94110