What side effects are associated with this type of intervention?

Common treatments for neck pain that are similar to cannabis (non-opioid analgesic and opioid-sparing therapy) include cannabinoids like THC and CBD. These treatments can have side effects such as somnolence (drowsiness), dizziness, and an increased risk of adverse events. Other non-opioid analgesics, such as NSAIDs, may cause gastrointestinal issues, cardiovascular risks, and renal impairment. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain conditions, including non-opioid analgesics and opioid-sparing therapies. While specific approvals for neck pain are not detailed, treatments such as NSAIDs (e.g., ibuprofen, naproxen) and muscle relaxants (e.g., cyclobenzaprine) are commonly used. Additionally, cannabinoids like nabiximols have been studied for their analgesic properties and potential to reduce opioid use, although their efficacy in neck pain specifically remains under investigation. These treatments aim to provide pain relief while minimizing the reliance on opioids.

What other types of research exist?

Promising, novel alternatives to cannabis for neck pain patients include: 1) Topical lidocaine, which has shown efficacy in neuropathic pain management; 2) Capsaicin 8% patches, which are effective for peripheral neuropathic pain; 3) Gabapentin, which is used for neuropathic pain and has shown benefits in reducing pain and improving function; 4) Ketamine infusions, which are emerging as a potential therapy for chronic pain with mixed results but promising potential. These alternatives offer non-opioid analgesic and opioid-sparing options for managing neck pain.

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Cannabinoid

Cannabis for Chronic Back Pain

Phase 3

Waitlist Available

Led By Emily Lindley, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Neuropathic Pain

Unwilling/unable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study (Analgesia Arm Exclusion Criteria)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 5, 13 and 21 (analgesia arm) week 12 (reduction arm)

Awards & highlights

Pivotal Trial

Summary

This trial tests if taking cannabis by mouth can help people with chronic spine pain reduce their use of opioids. It aims to see if cannabis can manage pain and lessen the need for opioids, as well as help with cravings and withdrawal symptoms. Cannabis has a long history of use for pain relief and is being studied for its potential to reduce opioid use in chronic pain management.

Who is the study for?

This trial is for adults with chronic, non-radiating spine pain lasting over 3 months. Participants must not have used cannabis or opioids recently and should be free from certain health conditions like cancer-related pain, neuropathic pain, recent major surgery, substance abuse disorders, significant mental health issues, cardiovascular disease, liver dysfunction or severe depression.

What is being tested?

The study tests the safety and effectiveness of oral cannabis (THC/CBD combination or THC alone) compared to a placebo in reducing chronic spine pain and potentially decreasing opioid use. The goal is to see if cannabis can serve as an alternative to opioids for long-term pain management.

What are the potential side effects?

Possible side effects of oral cannabis may include dizziness, dry mouth, altered mental state (like feeling 'high'), anxiety or paranoia. These effects vary by individual and dosage. Participants will be monitored for any adverse reactions throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had back pain for 3 months or more that does not spread down my legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I suffer from nerve pain.

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I cannot stop taking opioids for 14 days before the study starts and during it.

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I have a known heart condition.

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I am currently taking medications like valproate or warfarin.

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I have not had major surgery in the last 3 months.

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I have a history of seizures.

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I have liver problems or tests showing liver issues.

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I am currently having thoughts about harming myself.

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I have a cognitive condition that makes it hard for me to understand or agree to the study.

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I have an autoimmune disease like RA or MS.

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I am currently breastfeeding.

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I am scheduled for surgery or a procedure during the study.

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I have pain related to my cancer.

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I have a pain condition more severe than my back pain.

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I have been diagnosed with a cognitive impairment such as Alzheimer's or had a traumatic brain injury.

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I have had severe depression in the past or have it now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 5, 13 and 21 (analgesia arm) week 12 (reduction arm)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 5, 13 and 21 (analgesia arm) week 12 (reduction arm)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 5, 13 and 21 (analgesia arm) week 12 (reduction arm) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in abuse liability of cannabis as measured on a VAS for study drug (cannabis) craving

Change in abuse liability of cannabis as measured on the Drug Effects Questionnaire (DEQ) for study drug (cannabis)

Change in cognition and motor skills as assessed by the Hopkins Verbal Learning Test Revised (HVLT-R)

+16 more

Other study objectives

Change in 2-arachidonoylglycerol levels as measured in plasma

Change in C-reactive protein (CRP) levels as measured in plasma

Change in N-arachidonoylethanolamine levels as measured in plasma

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Reduction Arm: THC/CBDExperimental Treatment1 Intervention

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 II: Analgesia Arm: THC/CBD, then THC, then PlaceboExperimental Treatment3 Interventions

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 III: Analgesia Arm: THC/CBD, then Placebo, then THCExperimental Treatment3 Interventions

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 IV: Analgesia Arm: THC, then Placebo, then THC/CBDExperimental Treatment3 Interventions

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 V: Analgesia Arm: THC (tetrahydrocannabinol), then THC/CBD (cannabidiol), then PlaceboExperimental Treatment3 Interventions

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 VI: Analgesia Arm: Placebo, then THC/CBD, then THCExperimental Treatment3 Interventions

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 VII: Analgesia Arm: Placebo, then THC, then THC/CBDExperimental Treatment3 Interventions

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 VIII: Reduction Arm: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

THC/CBD

2014

N/A

~20

THC

2017

Completed Phase 1

~440

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for neck pain include non-opioid analgesics like NSAIDs, acetaminophen, and cannabinoids. NSAIDs work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing inflammation and pain. Acetaminophen acts centrally to inhibit prostaglandin synthesis, providing pain relief without significant anti-inflammatory effects. Cannabinoids, such as those found in medical cannabis, interact with the endocannabinoid system, modulating pain and inflammation through CB1 and CB2 receptors. These mechanisms are crucial for neck pain patients as they offer pain relief while minimizing the risk of opioid dependence and associated side effects, providing a safer and often more effective pain management strategy.