Pain Research: Innovative Strategies With Marijuana

NCT03522324 | Completed Results

• 1 other identifier: R01AT009541
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Chronic Low Back Pain; Cannabis Use

Keywords

Cannabis; Pain; Cytokines; Inflammation; Cognition

Outcome Measures

Primary Outcomes (4)

• Pain Interference: Roland Morris Disability Questionnaire (RMDQ)

  The Roland Morris Disability Questionnaire assesses self-rated physical disability caused by low back pain. Scores range from 0 to 24, with higher scores indicating more pain interference.

  Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).

• Inflammation: Circulating Levels of Cytokines

  Tests levels of recent inflammation (panel of inflammatory markers) before and after cannabis use. Higher numbers indicate higher levels of circulating pro-inflammatory cytokines. Results are in pg/mL and are separated by the three cytokines: IL-1b, IL-6, and IL-10.

  Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use) and Pre-Administration (after 2 weeks of use and before acute administration).

• Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)

  Co-outcomes testing cognitive impairment in the domains of immediate and delayed recall (ISLT) and attention and inhibitory control (FICA). Cognitive outcomes are measured in standard scores (e.g. Range of \>70 to \>140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.

  Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).

• Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)

  Subjective report of cognitive function using the Perceived Cognitive Impairments subscale of the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Possible scores range from 0-80 where higher scores are associated with higher levels of perceived impairment.

  Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).

Secondary Outcomes (7)

• Pain Intensity: Current Pain Using NIH Pain Intensity Scale.

  Change over 2 weeks

• Health & Wellbeing

  Change over 2 weeks

• Pittsburgh Sleep Quality Assessment (PSQI)

  Change over 4 weeks

• Motor Function

  Change over 2 weeks

• Depression and Stress

  Change over 2 weeks

Other Outcomes (4)

• Exploratory: Daily Follow-up Messages

  2 weeks (daily)

• Exploratory: Monthly Follow-up Surveys

  6 months (monthly)

• Objective Physical Activity/Exercise

  2 weeks

Interventions

Cannabis Edible DRUG

Self-Directed Use (ad-libitum)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator
• Colorado State University: collaborator

Study Sites (1)

Center for Innovation and Creativity

Boulder, Colorado, 80304, United States

Location

Related Publications (1)

• Melendez SN, Ortiz Torres M, Lisano JK, Giordano G, Skrzynski C, Hutchison KE, Bryan AD, Bidwell LC. Edible cannabis for chronic low back pain: associations with pain, mood, and intoxication. Front Pharmacol. 2024 Sep 24;15:1464005. doi: 10.3389/fphar.2024.1464005. eCollection 2024.

  PMID: 39380911 DERIVED

Related Links

• CUChange Lab, University of Colorado, Boulder

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected for cytokine and cannabinoid quantitation.

MeSH Terms

Conditions

Chronic Pain; Marijuana Abuse; Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes

Results Point of Contact

• Title: Dr. L. Cinnamon Bidwell
• Organization: University of Colorado Boulder

lcb@colorado.edu

3037355180

Study Officials

• Cinnamon Bidwell, PhD

  Institute of Cognitive Science, University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 11, 2018
• Study Start: June 1, 2018
• Primary Completion: April 10, 2023
• Study Completion: October 12, 2023
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)