Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

NCT ID: NCT05052541

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-06-30

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.

Detailed Description

This randomized, placebo-controlled clinical trial is designed to elucidate the role of extended oral cannabis treatment in the alleviation of chronic spine pain and reduction of high-dose opioid use. This trial includes two study arms: Analgesia Arm and Reduction Arm. The Analgesia Arm uses a within-subject crossover design to determine whether daily treatment with an oral cannabis solution for 6 weeks significantly reduces spine pain compared to placebo. The Reduction Arm uses a parallel design to determine whether daily treatment with an oral cannabis solution for 13 weeks results in a greater reduction of pain and opioid intake than placebo treatment. It will also assess the impact of extended cannabis treatment on opioid craving and symptoms of opioid withdrawal in participants tapering their high-dose opioids.

Conditions

Back Pain; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

THC

Intervention Type: DRUG

Oral solution containing 5mg THC per 1 ml

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

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

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

THC

Intervention Type: DRUG

Oral solution containing 5mg THC per 1 ml

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

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

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

THC

Intervention Type: DRUG

Oral solution containing 5mg THC per 1 ml

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

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

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

THC

Intervention Type: DRUG

Oral solution containing 5mg THC per 1 ml

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

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

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

THC

Intervention Type: DRUG

Oral solution containing 5mg THC per 1 ml

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

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

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

THC

Intervention Type: DRUG

Oral solution containing 5mg THC per 1 ml

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

Reduction Arm: THC/CBD

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.

Group Type: EXPERIMENTAL

THC/CBD

Intervention Type: DRUG

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

Reduction Arm: Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral solution containing no active drug

Interventions

THC/CBD

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

Intervention Type: DRUG

THC

Oral solution containing 5mg THC per 1 ml

Intervention Type: DRUG

Placebo

Oral solution containing no active drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Self-reported chronic (≥3 months' duration), non-radicular spine pain

Exclusion Criteria

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

History of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant

Current or historical severe depression

Current suicidal ideation

Diagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury)

Uncontrolled hypertension (>139/89)

Abnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician

Known hepatic disease or dysfunction, or identification of such on screening laboratory studies

Known cardiovascular disease

Abnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD

Cognitive disability that interferes with ability to provide consent or understand study procedure

History of seizure disorder

Any medical condition for which immunosuppressive therapy is required.

Inability to refrain from using tobacco for at least 4 hours

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data

Pending legal action or workers compensation

Pregnant females or females intending to become pregnant during the study period

Unwilling to use one of the accepted forms of contraception during the study period and for at least 60 days after completion of the study (females of childbearing potential and males with sexual partners of childbearing potential)

Lactating females

Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study

Not interested in reducing or discontinuing use of prescribed opioids for chronic pain

Unwilling to allow the study team to communicate with the participant's opioid prescribing provider

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Cannabis Research

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Lindley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mustafa Al-Mafrachi, MPH

Role: CONTACT

spinepainstudy@cuanschutz.edu

303-724-0923

Facility Contacts

Emily Lindley, PhD

Role: primary

emily.lindley@cuanschutz.edu

303-724-0239

Other Identifiers

20-0701

Identifier Type: -

Identifier Source: org_study_id