Back PainPhase 3NCT02892591
Cannabis Versus Oxycodone for Pain Relief
A Phase 3 study testing Cannabis and Oxycodone in people with Back Pain and Neck Pain, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- Cannabis and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 7 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone
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.
Read the 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.
- Being tested
- Cannabis, Oxycodone, Placebo for Cannabis, Placebo for Oxycodone
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called marijuana
vaporized plant material
OxycodoneDrug
oral capsule
Placebo for CannabisDrug
vaporized placebo plant material
Placebo for OxycodoneDrug
oral placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Cannabis | Experimental | Medium dose THC, single administration, vaporized Receives: Drug: Cannabis; Drug: Placebo for Oxycodone |
| Oxycodone | Active comparator | 5-10 mg oxycodone hydrochloride, single administration, oral Receives: Drug: Oxycodone; Drug: Placebo for Cannabis |
| Placebo | Placebo comparator | No active study drug Receives: Drug: Placebo for Cannabis; Drug: Placebo for Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numeric Rating Scale (NRS) score (Spine Patients)
Measured: 3 hours
Pain Threshold (kPa) (Healthy Controls)
Measured: 3 hours
Secondary outcomes (7)
Patient Global Impression of Change score
Measured: 3 hours
Drug effect rating
Measured: 3 hours
Psychoactive effect rating
Measured: 3 hours
Mood rating
Measured: 3 hours
Symbol Digit Modalities Test (SDMT)
Measured: 3 hours
Hopkins Verbal Learning Test Revised (HVLT)
Measured: 3 hours
Standardized Field Sobriety Test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start1 Jun 2017
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Lindley, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892591
- Sponsor's protocol ID
- 14-1909
- Status last verified
- Feb 2024
- First submitted
- 2 Sep 2016
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone
- ClinicalTrials.gov ID
- NCT02892591
- Acronym / sponsor ID
- 14-1909
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabis | Experimental | Drug: Cannabis, Drug: Placebo for OxycodoneMedium dose THC, single administration, vaporized |
| Oxycodone | Active comparator | Drug: Oxycodone, Drug: Placebo for Cannabis5-10 mg oxycodone hydrochloride, single administration, oral |
| Placebo | Placebo comparator | Drug: Placebo for Cannabis, Drug: Placebo for OxycodoneNo active study drug |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CannabisAlso: marijuanavaporized plant material | Drug | Cannabis |
| Oxycodoneoral capsule | Drug | Oxycodone |
| Placebo for Cannabisvaporized placebo plant material | Drug | Oxycodone, Placebo |
| Placebo for Oxycodoneoral placebo capsule | Drug | Cannabis, Placebo |
Primary outcome
Pain Numeric Rating Scale (NRS) score (Spine Patients)
Time frame: 3 hours
Pain Threshold (kPa) (Healthy Controls)
Time frame: 3 hours
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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.
Emily Lindley, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabis and Oxycodone in people with Back Pain and Neck Pain, run by University of Colorado, Denver 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?
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 22 Feb 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Numeric Rating Scale (NRS) score (Spine Patients) (time frame: 3 hours). The study lists 2 primary outcomes in all. 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 22 Feb 2024.