NCT05052541

Brief Summary

The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P25-P50 for phase_3

Timeline
13mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress25%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

August 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
4.3 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

August 18, 2021

Last Update Submit

January 21, 2026

Conditions

Back PainNeck Pain

Outcome Measures

Primary Outcomes (2)

  • Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain

    The Visual Analog Scale (VAS) for pain is a 0-100mm visual scale anchored by "no pain" and "worst possible pain".

    Weekly, up to week 22

  • Change in opioid dose as measured in morphine milligram equivalents (MME)

    Weekly, up to week 22

Secondary Outcomes (21)

  • Study Drug Tolerability as measured by study drug use

    Daily, up to week 22

  • Study Drug Tolerability as measured by side effects

    Daily, up to week 22

  • Change in spine-related disability and quality of life as measured on the NIH Patient Reported Outcomes Measurement System (PROMIS)-29

    Weekly, up to week 22

  • Change in spine-related disability and quality of life as measured on the NIH Task Force on Research Standards for Chronic Low-Back/Neck Pain Minimal Dataset

    Weekly, up to week 22

  • Change in use of opioid and non-opioid analgesic medications

    Daily, up to week 22

  • +16 more secondary outcomes

Other Outcomes (4)

  • Change in 2-arachidonoylglycerol levels as measured in plasma

    Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

  • Change in N-arachidonoylethanolamine levels as measured in plasma

    Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

  • Change in tumor necrosis factor alpha (TNF-α) levels as measured in plasma

    Baseline, Weeks 5, 13 and 21 (Analgesia Arm) Week 12 (Reduction Arm)

  • +1 more other outcomes

Study Arms (8)

Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then Placebo

EXPERIMENTAL

Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBDDrug: THCDrug: Placebo

Analgesia Arm: THC, then Placebo, then THC/CBD

EXPERIMENTAL

Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBDDrug: THCDrug: Placebo

Analgesia Arm: THC/CBD, then THC, then Placebo

EXPERIMENTAL

Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBDDrug: THCDrug: Placebo

Analgesia Arm: THC/CBD, then Placebo, then THC

EXPERIMENTAL

Subjects in this crossover arm will be assigned to 6 weeks on THC/CBD oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBDDrug: THCDrug: Placebo

Analgesia Arm: Placebo, then THC, then THC/CBD

EXPERIMENTAL

Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution, then 6 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBDDrug: THCDrug: Placebo

Analgesia Arm: Placebo, then THC/CBD, then THC

EXPERIMENTAL

Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC/CBD oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBDDrug: THCDrug: Placebo

Reduction Arm: THC/CBD

EXPERIMENTAL

Subjects in this parallel arm will be assigned to 13 weeks on THC/CBD oral solution. Frequency of drug administration is 3-4 times a day.

Drug: THC/CBD

Reduction Arm: Placebo

PLACEBO COMPARATOR

Subjects in this parallel arm will be assigned to 13 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.

Drug: Placebo

Interventions

THC/CBDDRUG

Oral solution containing 5mg THC and 50 mg CBD per 1 ml

Analgesia Arm: Placebo, then THC, then THC/CBDAnalgesia Arm: Placebo, then THC/CBD, then THCAnalgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then PlaceboAnalgesia Arm: THC, then Placebo, then THC/CBDAnalgesia Arm: THC/CBD, then Placebo, then THCAnalgesia Arm: THC/CBD, then THC, then PlaceboReduction Arm: THC/CBD
THCDRUG

Oral solution containing 5mg THC per 1 ml

Analgesia Arm: Placebo, then THC, then THC/CBDAnalgesia Arm: Placebo, then THC/CBD, then THCAnalgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then PlaceboAnalgesia Arm: THC, then Placebo, then THC/CBDAnalgesia Arm: THC/CBD, then Placebo, then THCAnalgesia Arm: THC/CBD, then THC, then Placebo
PlaceboDRUG

Oral solution containing no active drug

Analgesia Arm: Placebo, then THC, then THC/CBDAnalgesia Arm: Placebo, then THC/CBD, then THCAnalgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then PlaceboAnalgesia Arm: THC, then Placebo, then THC/CBDAnalgesia Arm: THC/CBD, then Placebo, then THCAnalgesia Arm: THC/CBD, then THC, then PlaceboReduction Arm: Placebo

Eligibility Criteria

Age21 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Self-reported chronic (≥3 months' duration), non-radicular spine pain
  • Unwilling/unable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than study drug). This includes whole plant inhalation, edibles, extracts, and topicals.
  • Co-morbid cancer-related pain condition
  • Neuropathic Pain
  • A co-morbid pain condition that is of greater severity than the patient's spine pain
  • Spine or other major surgery within the 3 months prior to enrollment
  • Planned surgery or procedural intervention during the study period
  • Allergy or adverse reaction to cannabis
  • Current or historical substance use disorder
  • Current or historical alcohol use disorder
  • Current or prior cannabis abuse/dependence
  • Positive result for use of amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen
  • Current use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines
  • Prior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)
  • History or diagnosis of schizophrenia, bipolar or a psychotic disorder
  • +21 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

RECRUITING

MeSH Terms

Conditions

Back PainNeck Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Emily Lindley, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Al-Mafrachi, MPH

CONTACT

303-724-0923spinepainstudy@cuanschutz.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: One Main Arm is Crossover (Analgesia Arm) One Main Arm is Parallel (Reduction Arm)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

September 22, 2021

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(1)