NCT02892591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

6 years

First QC Date

September 2, 2016

Last Update Submit

February 20, 2024

Conditions

Back PainNeck Pain

Outcome Measures

Primary Outcomes (2)

  • Pain Numeric Rating Scale (NRS) score (Spine Patients)

    3 hours

  • Pain Threshold (kPa) (Healthy Controls)

    3 hours

Secondary Outcomes (7)

  • Patient Global Impression of Change score

    3 hours

  • Drug effect rating

    3 hours

  • Psychoactive effect rating

    3 hours

  • Mood rating

    3 hours

  • Symbol Digit Modalities Test (SDMT)

    3 hours

  • +2 more secondary outcomes

Study Arms (3)

Cannabis

EXPERIMENTAL

Medium dose THC, single administration, vaporized

Drug: CannabisDrug: Placebo for Oxycodone

Oxycodone

ACTIVE COMPARATOR

5-10 mg oxycodone hydrochloride, single administration, oral

Drug: OxycodoneDrug: Placebo for Cannabis

Placebo

PLACEBO COMPARATOR

No active study drug

Drug: Placebo for CannabisDrug: Placebo for Oxycodone

Interventions

CannabisDRUG

vaporized plant material

Also known as: marijuana
Cannabis
OxycodoneDRUG

oral capsule

Oxycodone
Placebo for CannabisDRUG

vaporized placebo plant material

OxycodonePlacebo
Placebo for OxycodoneDRUG

oral placebo capsule

CannabisPlacebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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))
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Back PainNeck Pain

Interventions

nabiximolsOxycodone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Emily Lindley, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

June 1, 2017

Primary Completion

June 7, 2023

Study Completion

June 7, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

US(1)