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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03268551
Other study ID # 2017-7857
Secondary ID 1R01DA044171-01A
Status Completed
Phase
First received
Last updated
Start date September 4, 2018
Est. completion date July 14, 2023

Study information

Verified date November 2023
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 257
Est. completion date July 14, 2023
Est. primary completion date July 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years of age - English or Spanish fluency - New certification for medical cannabis within 90 days - No medical cannabis use in the 6 months prior to certification - Medical cannabis qualifying complication of "chronic or severe pain" - Use of prescribed or illicit opioid analgesics within 30 days Exclusion Criteria: - Inability to provide informed consent - Inability to complete study visits over 18 months - Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis, Parkinson's disease, inflammatory bowel disease, Hungtington's disease) - Terminal illness - Current or prior psychotic disorder

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Montefiore Health System Bronx New York
United States Vireo Health White Plains New York

Sponsors (4)

Lead Sponsor Collaborator
Albert Einstein College of Medicine Columbia University, Fordham University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid analgesic use The primary outcome will combine measures of prescribed and illicit opioid analgesic use. Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
Secondary 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. Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.
Secondary HIV viral load HIV viral load will be measured in copies/ml from blood samples collected during the study. HIV outcomes will be measured seven times every 3 months from baseline through 18 months.
Secondary CD4 count CD4 count will be measured in cells/mm3 from blood samples collected during the study. CD4 count will be measured seven times every 6 months from baseline through 18 months..
Secondary HIV antiretroviral adherence HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records. HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..
Secondary HIV risk behaviors HIV risk behaviors will be a composite measure from self-reported questionnaires. HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
Secondary Cannabis use disorder Cannabis use disorder will be measured using standardized instruments. Cannabis use disorder will be measured three times every 6 months.
Secondary Illicit drug use Illicit drug use will be measured using standardized surveys and urine toxicology testing. Illicit drug use will be measured seven times every 3 months from baseline through 18 months..
Secondary Diversion of medical cannabis Diversion will be measured using standardized surveys. Diversion will be measured seven times every 3 months from baseline through 18 months..
Secondary Non-fatal overdose Non-fatal overdose will be measured using standardized surveys. Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..
Secondary Death Death will be ascertained from the National Death Index Death will be measured 18 months after enrollment.
Secondary Accidents/Injuries Accidents/Injuries will be measured using standardized survey instruments Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
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