Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 18 for:    marijuana | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | ( Map: Colorado, United States )

Cannabis Versus Oxycodone for Pain Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892591
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE September 2, 2016
First Posted Date  ICMJE September 8, 2016
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2016)
  • Pain Numeric Rating Scale (NRS) score (Spine Patients) [ Time Frame: 3 hours ]
  • Pain Threshold (kPa) (Healthy Controls) [ Time Frame: 3 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02892591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Patient Global Impression of Change score [ Time Frame: 3 hours ]
  • Drug effect rating [ Time Frame: 3 hours ]
  • Psychoactive effect rating [ Time Frame: 3 hours ]
  • Mood rating [ Time Frame: 3 hours ]
  • Symbol Digit Modalities Test (SDMT) [ Time Frame: 3 hours ]
  • Hopkins Verbal Learning Test Revised (HVLT) [ Time Frame: 3 hours ]
  • Standardized Field Sobriety Test [ Time Frame: 3 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2016)
  • Patient Global Impression of Change score [ Time Frame: 3 hours ]
  • Drug effect rating [ Time Frame: 3 hours ]
  • Psychoactive effect rating [ Time Frame: 3 hours ]
  • Mood rating [ Time Frame: 3 hours ]
  • Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol Test [ Time Frame: 3 hours ]
  • Hopkins Verbal Learning Test Revised (HVLT) [ Time Frame: 3 hours ]
  • Standardized Field Sobriety Test [ Time Frame: 3 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabis Versus Oxycodone for Pain Relief
Official Title  ICMJE A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone
Brief Summary This study investigates the ability of cannabis to reduce chronic back and neck pain and to reduce sensitivity to an acute painful stimulus. Cannabis will be compared to both oxycodone and a placebo.
Detailed Description

This study investigates the ability of cannabis to reduce chronic back and neck pain and to reduce sensitivity to an acute painful stimulus. Cannabis will be compared to both oxycodone and a placebo.

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Back Pain
  • Neck Pain
Intervention  ICMJE
  • Drug: Cannabis
    vaporized plant material
    Other Name: marijuana
  • Drug: Oxycodone
    oral capsule
  • Drug: Placebo for Cannabis
    vaporized placebo plant material
  • Drug: Placebo for Oxycodone
    oral placebo capsule
Study Arms  ICMJE
  • Experimental: Cannabis
    Medium dose THC, single administration, vaporized
    Interventions:
    • Drug: Cannabis
    • Drug: Placebo for Oxycodone
  • Active Comparator: Oxycodone
    5-10 mg oxycodone hydrochloride, single administration, oral
    Interventions:
    • Drug: Oxycodone
    • Drug: Placebo for Cannabis
  • Placebo Comparator: Placebo
    No active study drug
    Interventions:
    • Drug: Placebo for Cannabis
    • Drug: Placebo for Oxycodone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Overall Inclusion Criteria:

  • Previous smoked or vaporized cannabis exposure
  • Age ≥21 years

Overall Exclusion Criteria:

  • Current substance use disorder
  • Current alcohol use disorder
  • Past cannabis abuse/dependence
  • Current use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), MDMA (ecstasy)
  • Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)
  • Allergy to or prior adverse reaction to oxycodone
  • Any condition contraindicative to opioid use (e.g. paralytic ileus)
  • History or diagnosis of schizophrenia or bipolar disorder
  • Current severe depression
  • Uncontrolled hypertension (>139/89)
  • Known cardiovascular disease
  • Known immune system disorder
  • Chronic pulmonary disease (e.g., bronchitis, asthma, COPD, or emphysema)
  • History of seizure disorder
  • Diagnosed inflammatory disease (e.g. Rheumatoid Arthritis (RA))
  • Clinically significant abnormal values on CBC/CMP/EKG tests
  • Cognitive disability that interferes with ability to provide consent or understand study procedures
  • Inability to refrain from using tobacco for at least 4 hours
  • Pregnant females
  • Lactating females

Additional Exclusion Criteria for SPINE PATIENTS

  • Current regular use of a long acting opioid (e.g. OxyContin, MS Contin, other extended release formulas)
  • Current high-dose use of immediate release opioid
  • Current high-dose use of nerve-targeted medication
  • Other diagnosed chronic pain syndromes of greater severity than spine condition (e.g. knee pain )
  • Diagnosed Fibromyalgia
  • Neuropathy not associated with spine condition (e.g. diabetic neuropathy)

Additional Exclusion Criteria for HEALTHY CONTROLS

  • Current acute pain
  • Current chronic pain condition (e.g. fibromyalgia, neuropathy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Emily Lindley, PhD 303-724-0923 MJPainStudy@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02892591
Other Study ID Numbers  ICMJE 14-1909
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily Lindley, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP