An observational study in Opioid Use, Marijuana and Chronic Pain, sponsored by Albert Einstein College of Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Albert Einstein College of Medicine · Observational
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Among 11 studies in Chronic Pain by Albert Einstein College of Medicine — none open to participants now, 2 under way, none of them phase 3. Chronic Pain · Albert Einstein College of Medicine.
Among the 11 studies in Chronic Pain by Albert Einstein College of Medicine, this one is the only one that started in 2018, is one of 2 observational ones, and was the 3rd registered.
3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.
Browse Chronic Pain studies →None of the 11 studies in Chronic Pain by Albert Einstein College of Medicine is open now. The open studies under Chronic Pain, anywhere →
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2018.
This study's enrollment of 257 is above the median of 120 across 753 observational studies indexed under Chronic Pain.
Median enrollment 18 across the 9 interventional studies, 237 across the 2 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.
1 of the studies in Chronic Pain by Albert Einstein College of Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05039554Albert Einstein College of MedicineRandomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment | 2027-04-29 |
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Among the 11 studies in Chronic Pain by Albert Einstein College of Medicine, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The study will examine how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and severe adverse events.
The overarching goal of the study is to understand how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis. Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week time period (unit of analysis), the primary exposure measure will be number of days of medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative findings will help understand the reasons underlying the findings of the cohort study.
Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Opioid analgesic use
The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
Time frame: Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
Alternative measures of opioid analgesic use
Alternative measures of opioid analgesic use will include: number of days of all opioid analgesic use, mean daily dose of all opioid analgesics, cumulative dose of prescribed (only) opioid analgesics, number of days of prescribed (only) opioid analgesic use, and mean daily dose of prescribed (only) opioid analgesic use.
Time frame: Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.
HIV viral load
HIV viral load will be measured in copies/ml from blood samples collected during the study.
Time frame: HIV outcomes will be measured seven times every 3 months from baseline through 18 months.
CD4 count
CD4 count will be measured in cells/mm3 from blood samples collected during the study.
Time frame: CD4 count will be measured seven times every 6 months from baseline through 18 months..
HIV antiretroviral adherence
HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.
Time frame: HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..
HIV risk behaviors
HIV risk behaviors will be a composite measure from self-reported questionnaires.
Time frame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
Cannabis use disorder
Cannabis use disorder will be measured using standardized instruments.
Time frame: Cannabis use disorder will be measured three times every 6 months.
Illicit drug use
Illicit drug use will be measured using standardized surveys and urine toxicology testing.
Time frame: Illicit drug use will be measured seven times every 3 months from baseline through 18 months..
Diversion of medical cannabis
Diversion will be measured using standardized surveys.
Time frame: Diversion will be measured seven times every 3 months from baseline through 18 months..
Non-fatal overdose
Non-fatal overdose will be measured using standardized surveys.
Time frame: Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..
Death
Death will be ascertained from the National Death Index
Time frame: Death will be measured 18 months after enrollment.
Accidents/Injuries
Accidents/Injuries will be measured using standardized survey instruments
Time frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
Ran from Sep 2018 to primary completion in Jul 2023, 58 months.
Of 336 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 58 months is above that.
Counting every sponsor, half of 362 studies reached it within 24 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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