NCT04827992

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 5, 2025

Status Verified

October 1, 2025

Enrollment Period

3.7 years

First QC Date

March 29, 2021

Last Update Submit

November 3, 2025

Conditions

Opioid UsePainMarijuana Use

Keywords

OpioidMarijuanaPainneurocognitionDependenceBehavioral 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 will assess pain intensity and interference. The scale ranges from 0-30, with a higher score indicating greater pain intensity and interference. Collected daily by a self-reported online survey.

    Every post-baseline day until week 24

Secondary Outcomes (6)

  • 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

  • Mean Difference in Cannabis Use Disorder Symptoms at weeks 12 and 24

    Week 12, Week 24

  • +1 more secondary outcomes

Study Arms (2)

Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment

EXPERIMENTAL

This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.

Drug: Medical MarijuanaBehavioral: Prescription Opioid Taper Support (POTS)

Prescription Opioid Taper Support (POTS) treatment alone

ACTIVE COMPARATOR

This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.

Behavioral: Prescription Opioid Taper Support (POTS)

Interventions

Medical MarijuanaDRUG

Patients in this group can choose what type, how much, and when to use medical marijuana to use.

Also known as: Cannabis
Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
Prescription Opioid Taper Support (POTS)BEHAVIORAL

Prescription Opioid Taper Support (POTS), a manualized behavioral prescription opioid taper support intervention developed by consultant, will be offered weekly to all participants to support behavioral self-management of pain and structured, voluntary taper of COT dose.

Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatmentPrescription Opioid Taper Support (POTS) treatment alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 35680252BACKGROUND

MeSH Terms

Conditions

PainMarijuana UseMarijuana Abuse

Interventions

Medical Marijuananabiximols

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSubstance-Related DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Jodi Gilman, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • A. Eden Evins, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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

November 5, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

All data, code, and materials used in the analyses can be provided by Jodi Gilman and Massachusetts General Hospital pending scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Requests for all materials should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu.

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)