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

NCT ID: NCT04827992

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2025-10-31

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).

Detailed Description

This trial is a randomized, six-month study of medical marijuana (MM) on opioid use that will: (1) evaluate whether adults with chronic, non-cancer pain on COT assigned to MM+POTS, compared with those assigned to WL+POTS, have greater reduction in opioid dose and/or pain intensity and interference, (2) assess whether participants assigned to MM+POTS, compared with those assigned to WL+POTS, have improved quality of life, depression, and anxiety; and reduced self-reported opioid dose, (3) evaluate whether those assigned to MM+POTS develop symptoms of CUD and have a reduced number of OUD symptoms over the 24-week intervention, as well as at the 12-month time point.

Participants will be randomly assigned to either an active MM arm (n = 60), or to a waitlist control arm (WLC) (n = 60). Participants will be assessed at baseline, every 4 weeks for 6 months, and at a 12-month follow-up for opioid use, development of CUD, development or resolution of OUD, and neurocognitive performance. Urine collected will be assessed with quantitative assays.

Conditions

Opioid Use; Pain; Marijuana Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Medical Marijuana

Intervention Type: DRUG

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

Prescription Opioid Taper Support (POTS)

Intervention Type: 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.

Prescription Opioid Taper Support (POTS) treatment alone

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

Group Type: ACTIVE_COMPARATOR

Prescription Opioid Taper Support (POTS)

Intervention Type: 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.

Interventions

Medical Marijuana

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

Intervention Type: DRUG

Prescription Opioid Taper Support (POTS)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cannabis

Eligibility Criteria

Inclusion Criteria

1. Men and women aged 18-75, inclusive.

2. Endorsing > 6 months of chronic, non-cancer pain.

3. On stable prescription opioid doses of 25 MME or greater for >90 days, verified by the Prescription Monitoring Program.

4. Either no prior use or current light cannabis use (weekly or less in the past 12 months).

5. Plans to use medical cannabis for pain to control pain and/or reduce opioid dose.

6. Competent and willing to provide written informed consent in English.

7. 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.

Exclusion Criteria

1. 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).

2. Current cannabis use disorder; current moderate to severe substance use disorder for any substance by structured interview, EXCEPT nicotine and opioids (OUD).

3. Current uncontrolled major medical illness, such as cancer, symptomatic hypothyroidism/hyperthyroidism or severe respiratory compromise.

4. Use of non-prescribed opioids, by self-report.

5. Dose change or initiation of medications with significant analgesic effects (e.g., tricyclic antidepressants, SSRIs, gabapentin, NSAIDs) in the past 4 weeks.

6. 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.

7. Actively suicidal and/or suicide attempt or psychiatric hospitalization in past year, or current suicidal ideation with specific plan or intent.

8. History of intellectual disability (e.g., Down's syndrome) or other severe developmental disorder or IQ < 70.

9. 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.

10. Surgery within the past month or planned during the next 6 months.

11. Pregnant or trying to get pregnant or breastfeeding.

12. In the opinion of the investigator or study physicians, not able to complete study procedures or safely participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge Health Alliance

OTHER

Sponsor Role: collaborator

MaineHealth

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jodi Gilman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jodi Gilman, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

A. Eden Evins, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Maine Medical Center

Portland, Maine, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Cambridge Health Alliance

Cambridge, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35680252 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA051540

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021P000871

Identifier Type: -

Identifier Source: org_study_id