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

Completed · Not applicable

Conditions studied: Opioid Use, Pain, Marijuana Use

In brief

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).

Key facts

Study ID

NCT04827992

Run by

Massachusetts General Hospital

People needed

87

Starts

2021-08-23

Expected to finish

2025-10-31

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Cambridge Health Alliance — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.