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Medical Cannabis + Opioid Tapering for Chronic Pain
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
- Group 2: Prescription Opioid Taper Support (POTS) treatment alone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is the enrollment phase of this experiment currently open?
"According to clinicaltrials.gov, this medical study is currently gathering participants; the initial posting was on August 23rd 2021 and it has been updated most recently on July 28th 2022."
What are the key goals of this research endeavor?
"The primary outcome measure of this experiment, taken from baseline to 6 months, is a shift in opioid consumption. Secondary outcomes include the Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at weeks 4, 8, 12, 16, 20 and 24 (measured on a t-score metric), the Self-Reported Opioid Dose at weeks 4, 8, 12 ,16 ,20 and 24 as well as changes to Quality of Life measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form which ranges from 14 - 70 with lower scores representing greater dissatisfaction."
Does this trial involve any groundbreaking techniques?
"Presently, there are 31 ongoing trials concerning Medical Marijuana around the world in 32 cities across 5 nations. The inaugural study for this field of medicine was undertaken by Jazz Pharmaceuticals and involved 200 patients; it navigated its Phase 2 & 3 processes in 2015. Since that time, 61 other studies have been launched."
Are there any specific prerequisites for individuals wanting to partake in this experiment?
"Patients who partake in the consumption of marijuana and are between the ages 18 - 75 may qualify for this trial. An estimation of 250 participants is expected to join."
Have there been prior experiments conducted with Medical Marijuana?
"Currently, 31 clinical trials are actively researching the medical applications of marijuana with 3 in their final stage. Most studies take place in Hartford, Connecticut; however, there are 46 centres nationwide conducting research on cannabis."
What is the enrollment capacity for this clinical trial?
"Affirmative. Clinicaltrials.gov provides evidence that this experimental trial, which was originally posted on August 23rd 2021, is still recruiting patients. Across 3 different medical facilities, 250 individuals are needed to fill the study's quota."
Are those aged 80 and above eligible to participate in this medical trial?
"This medical trial is open to individuals aged 18-75. Additionally, there are 103 studies designed for below the age of consent and 417 specifically tailored to those over 65 years old."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Most responsive sites:
- Cambridge Health Alliance: < 48 hours
Average response time
- < 2 Days
Typically responds via
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