PainPhase 1NCT00308555
Opioid and Cannabinoid Pharmacokinetic Interactions
A Phase 1 study testing Cannabis in people with Pain, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Consortium
San Francisco, California, 94110
About this study
Official title: Opioid and Cannabinoid Pharmacokinetic Interactions: A Pilot Study
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.
Read the detailed description
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 chronic pain 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.
- Conditions
- Pain
- Being tested
- Cannabis
- Keywords
- Cannabis, Morphine, Oxycodone, Marijuana, chronic pain
- Medical subject headings
- Pain, Marijuana Abuse, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
| Study group | Role | What they receive |
|---|---|---|
| Cannabis | Other | Not described Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Donald I Abrams, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308555
- Sponsor's protocol ID
- CC # 064
- Other IDs
- 1R21DA020831-01
- Status last verified
- Oct 2016
- First submitted
- 27 Mar 2006
- Last updated
- 9 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid and Cannabinoid Pharmacokinetic Interactions: A Pilot Study
- ClinicalTrials.gov ID
- NCT00308555
- Acronym / sponsor ID
- CC # 064
- Conditions
- Pain
- Keywords
- Cannabis, Morphine, Oxycodone, Marijuana, chronic pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Posted 22 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 chronic pain 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabis | Other | Drug: Cannabis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis | Drug | Cannabis |
Primary outcome
Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use
Time frame: Day 1, Day 5
Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald I Abrams, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis in people with Pain, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use (time frame: Day 1, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.