N/A
N=253
Pain Research: Innovative Strategies With Marijuana
Chronic Pain · Chronic Low Back Pain · Cannabis Use
Bottom Line
View on ClinicalTrials.gov: NCT03522324 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Pain Interference: Roland Morris Disability Questionnaire (RMDQ) — 8.028; 9.635; 9.034; 6.194 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cannabis Edible (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Boulder
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Interference: Roland Morris Disability Questionnaire (RMDQ) |
8.028; 9.635; 9.034; 6.194; 8.031; 7.419 | — |
| PRIMARY Inflammation: Circulating Levels of Cytokines |
6.685; 8.422; 7.829; 6.816; 8.031; 8.014 | — |
| PRIMARY Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT) |
101.806; 98.606; 99.974; 102.667; 100.207; 101.063 | — |
| PRIMARY Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) |
15.528; 14.14; 13.978; 12.52; 14.037; 12.743 | — |
| SECONDARY Pain Intensity: Current Pain Using NIH Pain Intensity Scale. |
2.2; 2.366; 2.448; 3.091; 3.204; 3.288 | — |
| SECONDARY Health & Wellbeing |
1.58; 1.56; 1.44; 1.54; 1.64; 1.50 | — |
| SECONDARY Pittsburgh Sleep Quality Assessment (PSQI) |
8.22; 8.39; 7.46; 5.85; 7.07; 6.14 | — |
| SECONDARY Motor Function |
0.019; 0.023; 0.021; 0.018; 0.023; 0.02 | — |
| SECONDARY Depression and Stress |
7.111; 6.188; 6.872; 5.939; 5.532; 5.856 | — |
| SECONDARY Acute Cognitive Impairment: Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Task (ISLT). |
100.619; 98.281; 100.904; 101.675; 99.615; 100.91 | — |
| SECONDARY Patient Global Impression of Change: Global Impression of Change Scale (PGIC). |
4.97; 4.745; 4.856 | — |
Summary
This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a two-week period, participants use an edible product of their choice. Blood levels of 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and after the two-week exposure period to determine whether there are associations with pain, inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After the two-week self-administration period, participants will be followed for six months to collect self-report data on cannabis use, pain levels, sleep quality, and mental health symptoms.
Eligibility Criteria
Inclusion Criteria
- Intent to initiate use of marijuana to treat chronic pain
- At least one episode of lifetime marijuana use, but infrequent marijuana use for prior six months
- Self-reported non-specific chronic low back pain for at least three months
- Health eligibility approved by study physician
- At least mild to moderate pain intensity OR pain interferes with important life functions
Exclusion Criteria
- Other drug use (cocaine, methamphetamine, etc.) in the past 3 days and/or actively seeking or in treatment for any substance use disorder
- Use of marijuana to treat pain at any time in lives
- Current use of psychotropic medications (other than SSRIs and ADHD meds), or use of antivirals, steroids, or regular use of maximal doses of NSAIDS
- A daily tobacco user
- Are currently pregnant or trying to become pregnant
- Acute illness (other than chronic pain) or any immune-related disease (e.g., HIV)
Data sourced from ClinicalTrials.gov (NCT03522324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.