Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Op… (NCT04827992) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
United States87 participantsStarted 2021-08-23
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 not be pregnant at enrollment. They will be asked to self-report pregnancy status and the start date of their most recent menstrual period 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.
What they're measuring
1
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
Timeframe: Week 24
2
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score over post-baseline to week 24 interval
✕. 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.