Back to resultsEvaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Primary Purpose
Opioid Use, Pain, Marijuana Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Marijuana
Prescription Opioid Taper Support (POTS)
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use focused on measuring Opioid, Marijuana, Pain, neurocognition, Dependence, Behavioral treatment
Eligibility Criteria
Inclusion Criteria:
- 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 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:
- 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.
Sites / Locations
- Maine Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- Cambridge Health AllianceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
Prescription Opioid Taper Support (POTS) treatment alone
Arm Description
This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.
This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.
Outcomes
Primary Outcome Measures
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
Opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day. If participants decide to reduce dose at week 24, we will use the reduced dose even if the new dose cannot be immediately implemented (e.g., due to delays in refilling prescription) to ensure accurate representation of change.
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.
Secondary Outcome Measures
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at weeks 4, 8, 12, 16, 20, 24
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form will assess changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life.
Mean Difference in PROMIS-29 Depression Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression.
Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety.
Mean Difference in Opioid Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
The DSM-5 Opioid Use Disorder Checklist will evaluate symptoms of Opioid Use Disorder (number of symptoms). The scale ranges from 0 - 11, with a higher score indicating more severe Opioid Use Disorder.
Mean Difference in Cannabis Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
The DSM-5 Cannabis Use Disorder Checklist will evaluate symptoms of Cannabis Use Disorder (number of symptoms). The scale ranges from 0 - 11, with a higher score indicating more severe Cannabis Use Disorder.
Mean Difference in Self-Reported Opioid Dose at weeks 4, 8, 12, 16, 20, 24
Self-reported opioid dose in morphine milligram equivalents (MME) per day. This is collected daily by a self-reported online survey and averaged over each 4-week interval.
Full Information
NCT ID
NCT04827992
First Posted
March 29, 2021
Last Updated
December 13, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Cambridge Health Alliance, MaineHealth
1. Study Identification
Unique Protocol Identification Number
NCT04827992
Brief Title
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Official Title
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Cambridge Health Alliance, MaineHealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 = 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 will be assessed with quantitative assays.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Marijuana Use
Keywords
Opioid, Marijuana, Pain, neurocognition, Dependence, Behavioral treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
Arm Type
Experimental
Arm Description
This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.
Arm Title
Prescription Opioid Taper Support (POTS) treatment alone
Arm Type
Active Comparator
Arm Description
This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.
Intervention Type
Drug
Intervention Name(s)
Medical Marijuana
Other Intervention Name(s)
Cannabis
Intervention Description
Patients in this group can choose what type, how much, and when to use medical marijuana to use.
Intervention Type
Behavioral
Intervention Name(s)
Prescription Opioid Taper Support (POTS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
Description
Opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day. If participants decide to reduce dose at week 24, we will use the reduced dose even if the new dose cannot be immediately implemented (e.g., due to delays in refilling prescription) to ensure accurate representation of change.
Time Frame
Baseline and week 24
Title
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score over post-baseline to week 24 interval
Description
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.
Time Frame
Every post-baseline day until week 24
Secondary Outcome Measure Information:
Title
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at weeks 4, 8, 12, 16, 20, 24
Description
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form will assess changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life.
Time Frame
Week 4, week 8, week 12, week 16, week 20, week 24
Title
Mean Difference in PROMIS-29 Depression Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
Description
The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression.
Time Frame
Week 4, week 8, week 12, week 16, week 20, week 24
Title
Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
Description
The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety.
Time Frame
Week 4, week 8, week 12, week 16, week 20, week 24
Title
Mean Difference in Opioid Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
Description
The DSM-5 Opioid Use Disorder Checklist will evaluate symptoms of Opioid Use Disorder (number of symptoms). The scale ranges from 0 - 11, with a higher score indicating more severe Opioid Use Disorder.
Time Frame
Week 4, week 8, week 12, week 16, week 20, week 24
Title
Mean Difference in Cannabis Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
Description
The DSM-5 Cannabis Use Disorder Checklist will evaluate symptoms of Cannabis Use Disorder (number of symptoms). The scale ranges from 0 - 11, with a higher score indicating more severe Cannabis Use Disorder.
Time Frame
Week 4, week 8, week 12, week 16, week 20, week 24
Title
Mean Difference in Self-Reported Opioid Dose at weeks 4, 8, 12, 16, 20, 24
Description
Self-reported opioid dose in morphine milligram equivalents (MME) per day. This is collected daily by a self-reported online survey and averaged over each 4-week interval.
Time Frame
Week 4, week 8, week 12, week 16, week 20, week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jodi Gilman, PhD
Phone
6176437293
Email
jgilman1@partners.org
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurora Quaye, MD
Email
aurora.quaye@spectrumhcp.com
First Name & Middle Initial & Last Name & Degree
Aurora Quaye, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Gilman
Phone
617-643-7293
Email
jgilman1@partners.org
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellie Grossman, MD
Email
egrossman@challiance.org
First Name & Middle Initial & Last Name & Degree
Ellie Grossman, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will become available beginning one year after publication of the results.
IPD Sharing 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
Citations:
PubMed Identifier
35680252
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
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