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

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

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 (CNCP) is associated with reduced opioid dose and improved pain severity when added to a 24-week behavioral intervention (POTS).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Analgesics, Opioid

Criteria

Inclusion Criteria:

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

2. Endorsing a pain rating at screening of at least 5 on a 10-point numeric rating scale

3. Endorsing > 6 months of CNCP, with neuropathic pain.

4. On stable prescription opioid doses for >90 days.

5. Either no prior use or current light cannabis use (monthly or less in the past 24 months).

6. Desire to use medical cannabis for pain to control pain and/or reduce opioid dose.

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

8. Potential participants of childbearing potential must have a negative urine pregnancy test at enrollment 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 of greater than monthly on average in the past 24 months, assessed via self-report.

2. Current substance use disorder on any substance (e.g., alcohol, cocaine, stimulant) by structured interview, EXCEPT nicotine or opioids (OUD).

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

4. Use of non-prescribed opioids, by self-report or urine toxicology screen.

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

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

7. Current diagnosis of delirium, dementia, amnestic, or other cognitive disorder; schizophrenia or other psychotic disorder; bipolar I or II disorder; clinically significant diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

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

9. Pregnant or trying to get pregnant or breastfeeding.

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