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Cannabis Versus Oxycodone for Pain Relief

Primary Purpose

Back Pain, Neck Pain

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Oxycodone
Placebo for Cannabis
Placebo for Oxycodone
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Cannabis

Oxycodone

Placebo

Arm Description

Medium dose THC, single administration, vaporized

5-10 mg oxycodone hydrochloride, single administration, oral

No active study drug

Outcomes

Primary Outcome Measures

Pain Numeric Rating Scale (NRS) score (Spine Patients)
Pain Threshold (kPa) (Healthy Controls)

Secondary Outcome Measures

Patient Global Impression of Change score
Drug effect rating
Psychoactive effect rating
Mood rating
Symbol Digit Modalities Test (SDMT)
Hopkins Verbal Learning Test Revised (HVLT)
Standardized Field Sobriety Test

Full Information

First Posted
September 2, 2016
Last Updated
November 2, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02892591
Brief Title
Cannabis Versus Oxycodone for Pain Relief
Official Title
A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabis
Arm Type
Experimental
Arm Description
Medium dose THC, single administration, vaporized
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
5-10 mg oxycodone hydrochloride, single administration, oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No active study drug
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
marijuana
Intervention Description
vaporized plant material
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for Cannabis
Intervention Description
vaporized placebo plant material
Intervention Type
Drug
Intervention Name(s)
Placebo for Oxycodone
Intervention Description
oral placebo capsule
Primary Outcome Measure Information:
Title
Pain Numeric Rating Scale (NRS) score (Spine Patients)
Time Frame
3 hours
Title
Pain Threshold (kPa) (Healthy Controls)
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change score
Time Frame
3 hours
Title
Drug effect rating
Time Frame
3 hours
Title
Psychoactive effect rating
Time Frame
3 hours
Title
Mood rating
Time Frame
3 hours
Title
Symbol Digit Modalities Test (SDMT)
Time Frame
3 hours
Title
Hopkins Verbal Learning Test Revised (HVLT)
Time Frame
3 hours
Title
Standardized Field Sobriety Test
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Lindley, PhD
Phone
303-724-0923
Email
MJPainStudy@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Lindley, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Lindley, PhD
Phone
303-724-0923
Email
MJPainStudy@ucdenver.edu

12. IPD Sharing Statement

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Cannabis Versus Oxycodone for Pain Relief

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