Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

Overview

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.

Interventions

• Drug THC/CBD
  Oral solution containing 5mg THC and 50 mg CBD per 1 ml
• Drug THC
  Oral solution containing 5mg THC per 1 ml
• Drug Placebo
  Oral solution containing no active drug

Primary outcome measures

• Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain [Time frame: Weekly, up to week 22]
• Change in opioid dose as measured in morphine milligram equivalents (MME) [Time frame: Weekly, up to week 22]

Secondary outcome measures (12)

• Study Drug Tolerability as measured by study drug use [Time frame: Daily, up to week 22]
• Study Drug Tolerability as measured by side effects [Time frame: 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 [Time frame: 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 [Time frame: Weekly, up to week 22]
• Change in use of opioid and non-opioid analgesic medications [Time frame: Daily, up to week 22]
• Change in abuse liability of cannabis as measured on the Drug Effects Questionnaire (DEQ) for study drug (cannabis) [Time frame: Weekly, up to week 22]
• Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving [Time frame: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on a VAS for opioid craving [Time frame: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on the Subjective Opiate Withdrawal Scale (SOWS) [Time frame: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on the Drug Effect Questionnaire (DEQ) [Time frame: Weekly, up to week 22]
• Change in opioid craving and withdrawal as measured on the Current Opioid Misuse Measure (COMM). [Time frame: Weekly, up to week 22]
• Change in pain sensitivity as measured by pain threshold (kPa) to a pressure stimulus [Time frame: Weekly, up to week 22]

Eligibility criteria

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

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

Analgesia Arm Exclusion Criteria:

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

Reduction Arm Exclusion Criteria:

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

\*Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT05052541 · 20-0701

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗