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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 5, 13 and 21 (analgesia arm) week 12 (reduction arm)
Awards & highlights

Study Summary

This trial will study if cannabis could be used to replace opioids or reduce high-dose opioid use in patients with chronic spine pain.

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.Check my eligibility
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.See study design
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
Select...
I have had back pain for 3 months or more that does not spread down my legs.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in chronic pain as measured by the Visual Analog Scale (VAS) for pain
Change in opioid dose as measured in morphine milligram equivalents (MME)
Secondary outcome measures
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)
+18 more
Other outcome measures
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

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
THC/CBD
2014
N/A
~20
THC
2017
Completed Phase 1
~330
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,533 Total Patients Enrolled
4 Trials studying Neck Pain
311 Patients Enrolled for Neck Pain
Colorado Department of Public Health and EnvironmentOTHER_GOV
10 Previous Clinical Trials
9,407 Total Patients Enrolled
Emily Lindley, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Neck Pain
33 Patients Enrolled for Neck Pain

Media Library

THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05052541 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we looking for test subjects that are over 20 years old?

"The age limit for this clinical trial is 21 to 84. If a patient does not meet this criteria, there are 21 other trials which might be more appropriate. For patients that are older than 65, there are 344 different trials from which to choose."

Answered by AI

Could you please outline the other research studies that have looked at THC/CBD?

"There are a total of 113 studies currently underway researching the medical benefits of THC/CBD. Of those, 21 have reached Phase 3 clinical trials. Even though most of the research is being conducted in Belmont, Massachusetts, there are 357 locations spread out across conducting these experiments."

Answered by AI

Could you please explain the requirements for this research project?

"The study is admitting 157 participants, who are aged 21 to 84 and have back pain. In order for patients to be eligible, they must also meet the following inclusion criteria: ____ ."

Answered by AI

For what ailments is THC/CBD oil most often recommended?

"THC/CBD is often used when patients do not respond well to other forms of treatment. This medication can also be helpful for those suffering from multiple sclerosis, pain, and other conditions."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried many different treatments and am hopeful marijuana will be able to finally relieve my pain.
PatientReceived 1 prior treatment
~20 spots leftby Jun 2024