Phase
Condition
Pain
Drug Use
Substance Abuse
Treatment
Medical Marijuana
Prescription Opioid Taper Support (POTS)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 bythe Prescription Monitoring Program.
Either no prior use or current light cannabis use (weekly or less in the past 12months).
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 not be pregnant at enrollment.They will be asked to self-report pregnancy status and the start date of their mostrecent menstrual period and agree to use effective contraception: abstinence;hormonal contraception; intra-uterine device, sterilization; or double barriercontraception, during the study.
Exclusion
Exclusion Criteria:
Current cannabis use (including inhaled or ingested CBD products) of greater thanweekly on average in the past 12 months, assessed via self-report (no more than 10times in the past 90 days).
Current cannabis use disorder; current moderate to severe substance use disorder forany substance by structured interview, EXCEPT nicotine and opioids (OUD).
Current uncontrolled major medical illness, such as cancer, symptomatichypothyroidism/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 medicationsthat may interact with cannabinoids (e.g., warfarin) will be discussed with a studyclinician prior to enrollment or continued participation.
Actively suicidal and/or suicide attempt or psychiatric hospitalization in pastyear, or current suicidal ideation with specific plan or intent.
History of intellectual disability (e.g., Down's syndrome) or other severedevelopmental 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 studyprocedures or safely participate in this study.
Study Design
Study Description
Connect with a study center
Maine Medical Center
Portland, Maine 04102
United StatesSite Not Available
Maine Medical Center
Portland 4975802, Maine 4971068 04102
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114-2523
United StatesSite Not Available
Cambridge Health Alliance
Cambridge, Massachusetts 02139
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114-2523
United StatesSite Not Available
Cambridge Health Alliance
Cambridge 4931972, Massachusetts 6254926 02139
United StatesSite Not Available

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