Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain

NCT04827992 | Completed Results DMC

• 2 other identifiers: 2021P000871R01DA051540
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 3

Brief Summary

This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).

Conditions

Opioid Use; Pain; Marijuana Use

Keywords

Opioid; Marijuana; Pain; neurocognition; Dependence; Behavioral treatment

Outcome Measures

Primary Outcomes (2)

• Mean Difference in Prescription Monitoring Program Verified Opioid Dose at Baseline and Week 24

  Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.

  Week 24

• Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score Over Post-baseline to Week 24 Interval

  The Pain, Enjoyment, General Activity (PEG) scale assesses pain intensity and interference. The scale ranges from 0 to 10, with a higher score indicating greater pain intensity and interference. PEG score was assessed daily through week 24 via daily self-report survey. From model fit to all post-baseline timepoints, adjusted marginal means at week 24 were computed as a summary measure.

  Every post-baseline day until week 24

Secondary Outcomes (6)

• Mean Difference in Self-Reported Opioid Dose Over Post-baseline to Week 24 Interval

  Every post-baseline day until week 24

• Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at Weeks 4, 8, 12, 16, 20, 24

  Week 4, week 8, week 12, week 16, week 20, week 24

• Mean Difference in PROMIS-29 Depression Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24

  Week 4, week 8, week 12, week 16, week 20, week 24

• Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at Weeks 4, 8, 12, 16, 20, 24

  Week 4, week 8, week 12, week 16, week 20, week 24

• Mean Difference in Opioid Use Disorder Symptoms at Weeks 4, 8, 12, 16, 20, 24

  Week 4, week 8, week 12, week 16, week 20, week 24

Study Arms (2)

Cannabis (CB)

EXPERIMENTAL

Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources. All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.

Drug: Cannabis; Behavioral: Prescription Opioid Taper Support (POTS)

Waitlist (WL)

ACTIVE COMPARATOR

Participants assigned to the waitlist control group agreed to delay cannabis use for 24 weeks. All study participants were offered weekly group Prescription Opioid Taper Support (POTS), a behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering, for 24 weeks.

Behavioral: Prescription Opioid Taper Support (POTS)

Interventions

Prescription Opioid Taper Support (POTS) BEHAVIORAL

All participants were offered weekly group Prescription Opioid Taper Support (POTS) sessions for 24 weeks. POTS is behavioral intervention promoting pain self-management and gradual, voluntary opioid tapering. This intervention was adapted for this trial to include group-based delivery. Sessions are one hour delivered via teleconference and incorporated cognitive behavioral, mindfulness-based, and motivational interviewing strategies.

Cannabis (CB); Waitlist (WL)

Cannabis DRUG

Participants assigned to the cannabis group were allowed to initiate cannabis use immediately. Participants selected cannabis product type(s), dose(s), and frequency of use from commercial sources.

Cannabis (CB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-75, inclusive.
• Endorsing \> 6 months of chronic, non-cancer pain.
• On stable prescription opioid doses of 25 MME or greater for \>90 days, verified by the Prescription Monitoring Program.
• Either no prior use or current light cannabis use (weekly or less in the past 12 months).
• Plans to use medical cannabis for pain to control pain and/or reduce opioid dose.
• Competent and willing to provide written informed consent in English.
• Potential participants of childbearing potential must not be pregnant at enrollment. They will be asked to self-report pregnancy status and the start date of their most recent menstrual period and agree to use effective contraception: abstinence; hormonal contraception; intra-uterine device, sterilization; or double barrier contraception, during the study.

You may not qualify if:

• Current cannabis use (including inhaled or ingested CBD products) of greater than weekly on average in the past 12 months, assessed via self-report (no more than 10 times in the past 90 days).
• Current cannabis use disorder; current moderate to severe substance use disorder for any substance by structured interview, EXCEPT nicotine and opioids (OUD).
• Current uncontrolled major medical illness, such as cancer, symptomatic hypothyroidism/hyperthyroidism or severe respiratory compromise.
• Use of non-prescribed opioids, by self-report.
• Dose change or initiation of medications with significant analgesic effects (e.g., tricyclic antidepressants, SSRIs, gabapentin, NSAIDs) in the past 4 weeks.
• Concomitant medications will be discussed at each study visit, and any medications that may interact with cannabinoids (e.g., warfarin) will be discussed with a study clinician prior to enrollment or continued participation.
• Actively suicidal and/or suicide attempt or psychiatric hospitalization in past year, or current suicidal ideation with specific plan or intent.
• History of intellectual disability (e.g., Down's syndrome) or other severe developmental disorder or IQ \< 70.
• Current diagnosis of delirium, dementia, amnestic, or other cognitive disorder; current diagnosis of bipolar II disorder; lifetime diagnosis of bipolar I disorder, schizophrenia spectrum, or other psychotic disorder.
• Surgery within the past month or planned during the next 6 months.
• Pregnant or trying to get pregnant or breastfeeding.
• In the opinion of the investigator or study physicians, not able to complete study procedures or safely participate in this study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Cambridge Health Alliance: collaborator
• MaineHealth: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2523, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (1)

• Jashinski J, Grossman E, Quaye A, Cather C, Potter K, Schoenfeld DA, Evins AE, Gilman JM. Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol. BMJ Open. 2022 Jun 9;12(6):e064457. doi: 10.1136/bmjopen-2022-064457.

  PMID: 35680252 BACKGROUND

MeSH Terms

Conditions

Pain; Marijuana Use; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations include the reliance on self-reported cannabis use, variability in cannabis products, and potential underpowering to detect small effect sizes.

Results Point of Contact

• Title: Jodi Gilman, PhD
• Organization: Massachusetts General Hospital

jgilman1@mgh.harvard.edu

6176437293

Study Officials

• Jodi Gilman, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• A. Eden Evins, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: August 23, 2021
• Primary Completion: May 1, 2025
• Study Completion: October 31, 2025
• Last Updated: June 24, 2026
• Results First Posted: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available beginning one year after publication of the results.
• Access Criteria: Data will be provided pending a scientific review and a completed data use agreement/material transfer agreement. Requests should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu

Locations

US (3)