Cannabis Versus Oxycodone for Pain Relief | NCT02892591

Studies
Cannabis Versus Oxycodone for Pain Relief

NCT02892591

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Feb 22, 2024Actual

Enrollment

33Actual

Phase

Phase 3

Conditions

Back Pain
Neck Pain

Interventions

Cannabis
Oxycodone
Placebo for Cannabis
Placebo for Oxycodone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jun 7, 2023Actual

Completion Date

Jun 7, 2023Actual

First Submitted Date

Sep 2, 2016

First Submission Date that Met QC Criteria

Sep 2, 2016

First Posted Date

Sep 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2024

Last Update Posted Date

Feb 22, 2024Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cannabis	Experimental	Medium dose THC, single administration, vaporized	Drug: Cannabis Drug: Placebo for Oxycodone
Oxycodone	Active Comparator	5-10 mg oxycodone hydrochloride, single administration, oral	Drug: Oxycodone Drug: Placebo for Cannabis
Placebo	Placebo Comparator	No active study drug	Drug: Placebo for Cannabis Drug: Placebo for Oxycodone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cannabis	Drug	vaporized plant material	Cannabis	marijuana

Measure	Description	Time Frame
Pain Numeric Rating Scale (NRS) score (Spine Patients)		3 hours
Pain Threshold (kPa) (Healthy Controls)		3 hours

Measure	Description	Time Frame
Patient Global Impression of Change score		3 hours
Drug effect rating		3 hours
Psychoactive effect rating

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C587251	nabiximols
D010098	Oxycodone

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

ID	Term
D001416	Back Pain
D019547	Neck Pain