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Medical Cannabis + Opioid Tapering for Chronic Pain
N/A
Recruiting
Led By Jodi Gilman, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Men and women aged 18-75, inclusive.
Must not have
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
Current uncontrolled major medical illness, such as cancer, symptomatic hypothyroidism/hyperthyroidism or severe respiratory compromise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 month
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether medical marijuana can help people on high doses of opioids for chronic pain. The study will last 24 weeks.
Who is the study for?
Adults aged 18-75 with chronic non-cancer pain, on stable opioid doses for over 90 days, who plan to use medical cannabis to manage pain or reduce opioids. Must not be heavy cannabis users, pregnant, or have severe health issues like cancer or major psychiatric disorders.
What is being tested?
The study is testing if medical marijuana plus a Prescription Opioid Taper Support program can help adults lower their opioid dosage and improve pain management compared to just the taper support program alone over a period of 24 weeks.
What are the potential side effects?
Medical marijuana may cause dizziness, dry mouth, altered mental state, and dependency with long-term use. The process of reducing opioid doses might lead to withdrawal symptoms such as anxiety, insomnia, nausea, and increased pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and agree to use effective birth control during the study.
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I am between 18 and 75 years old.
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I am between 18 and 75 years old.
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I have been experiencing pain not caused by cancer for over 6 months.
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I have had chronic pain for more than 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a current or past diagnosis of major psychiatric disorders.
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I do not have any severe illnesses like uncontrolled cancer or serious thyroid/respiratory issues.
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I have had surgery in the last month or will have it in the next 6 months.
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I use cannabis or CBD more than once a week but not more than 10 times in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score over post-baseline to week 24 interval
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
Secondary study objectives
Mean Difference in Cannabis Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
Mean Difference in Opioid Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
+3 moreOther study objectives
Changes in Cognitive Functioning: Attention
Changes in Cognitive Functioning: Verbal Memory
Changes in Cognitive Functioning: Working Memory
+3 moreSide effects data
From 2022 Phase 1 trial • 66 Patients • NCT032336332%
Panic Attack
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Medical Marijuana Treatment Arm
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatmentExperimental Treatment2 Interventions
This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.
Group II: Prescription Opioid Taper Support (POTS) treatment aloneActive Control1 Intervention
This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Marijuana
2017
Completed Phase 1
~360
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,604 Previous Clinical Trials
3,329,618 Total Patients Enrolled
34 Trials studying Cannabis Use
7,328 Patients Enrolled for Cannabis Use
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,691 Total Patients Enrolled
3 Trials studying Cannabis Use
407 Patients Enrolled for Cannabis Use
Cambridge Health AllianceOTHER
62 Previous Clinical Trials
22,359 Total Patients Enrolled
MaineHealthOTHER
74 Previous Clinical Trials
43,655 Total Patients Enrolled
Jodi Gilman, PhDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
1 Previous Clinical Trials
7 Total Patients Enrolled
A. Eden Evins, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks I can't safely follow the study's procedures.I plan to use medical cannabis for pain management or to lower my opioid use.I plan to use medical cannabis for pain management or to lower my opioid use.I do not have a current or past diagnosis of major psychiatric disorders.I am not pregnant and agree to use effective birth control during the study.I have been on a stable opioid dose of 25 MME or more for over 90 days.I have been on a stable opioid dose of 25 MME or more for over 90 days.You have not used cannabis before or you only use it occasionally (once a week or less in the past year).I haven't started or changed pain-relief medications in the last 4 weeks.I am between 18 and 75 years old.I do not have any severe illnesses like uncontrolled cancer or serious thyroid/respiratory issues.I will discuss all my medications with the study team to check for interactions.I have had surgery in the last month or will have it in the next 6 months.You currently have a serious problem with using drugs, except for nicotine and opioids (opioid use disorder).I am between 18 and 75 years old.I have been experiencing pain not caused by cancer for over 6 months.You haven't used cannabis regularly in the past year or currently use it only occasionally.I use cannabis or CBD more than once a week but not more than 10 times in the last 3 months.You are using opioids without a prescription.I have had chronic pain for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
- Group 2: Prescription Opioid Taper Support (POTS) treatment alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.