Purpose

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 intensity and interference when added to a 24-week behavioral intervention (POTS).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Men and women aged 18-75, inclusive. 2. Endorsing > 6 months of CNCP. 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 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 (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 tobacco and opioid use disorders. 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 or urine toxicology screen. 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Medical Marijuana
    Patients in this group can choose what type, how much, and when to use medical marijuana to use.
    Other names:
    • Cannabis
  • Behavioral: 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.
Active Comparator
Prescription Opioid Taper Support (POTS) treatment alone
This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.
  • Behavioral: 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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114-2523
Contact:
Jodi Gilman
617-643-7293
jgilman1@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Jodi Gilman, PhD
6176437293
jgilman1@partners.org

Detailed Description

This trial is a randomized, six-month study of medical marijuana (MM) on opioid use that will: (1) evaluate whether adults with CNCP 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 = 125), or to a waitlist control arm (WLC) (n = 125). 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 at each visit will be assessed with quantitative assays.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.