Opioid and Cannabinoid Pharmacokinetic Interactions

NCT00308555 | Completed Phase 1 Results

• 2 other identifiers: CC # 0641R21DA020831-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

We are conducting a study to assess whether smoking marijuana affects the safety of prescribed opioids in patients treated for chronic 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 chronic pain. We will also assess the clinical safety of cannabinoids and these opioids by monitoring the short-term side effects associated with combined therapy.

Conditions

Pain

Keywords

Cannabis; Morphine; Oxycodone; Marijuana; chronic pain

Outcome Measures

Primary Outcomes (1)

• Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use

  Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.

  Day 1, Day 5

Study Arms (1)

Cannabis

OTHER

Drug: Cannabis

Interventions

Cannabis DRUG

Cannabis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ongoing analgesic therapy with either oxycodone hydrochloride (OxyContin) or morphine sulfate (MS Contin) every 12 hours for chronic pain.
• Eligible subjects will be ≥ 18 years of age with a diagnosis of chronic pain and an estimated survival of greater than six months.
• Subjects must be on a stable dose of opioid medication for at least 2 weeks before enrollment.
• 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.
• 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)
• 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).
• 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.
• Prior history of use of marijuana. Subjects must have smoked marijuana on at least 6 occasions in their lifetime prior to enrollment.
• Able to understand and follow the instructions of the investigator, including completing the pain intensity rating scales.
• Karnofsky Performance Score \>60.
• Able and willing to provide informed consent.

You may not qualify if:

• 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.
• History of renal or hepatic failure.
• Evidence of hepatic, hematological or renal dysfunction based on judgment of physician.
• Active substance abuse (e.g., alcohol or injection drugs).
• Use of smoked marijuana within 30 days of enrollment verified with a urine THC level.
• Neurologic dysfunction or psychiatric disorder severe enough to interfere with assessment of pain or sensory systems.
• Current use of smoked tobacco products or a confirmed cotinine level.
• Women who are pregnant or breast-feeding may not take part in this study.
• Unable to read or speak English.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Community Consortium

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Pain; Marijuana Abuse; Chronic Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Donald I. Abrams
• Organization: UCSF/San Francisco General Hospital

dabrams@hemeonc.ucsf.edu

415-476-4082

Study Officials

• Donald I Abrams, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 29, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 9, 2016
• Results First Posted: July 22, 2013

Record last verified: 2016-10

Locations

US (1)