Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

MEMO-Medical Marijuana and Opioids Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03268551
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Fordham University
Columbia University
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Chinazo Cunningham, Albert Einstein College of Medicine

Tracking Information
First Submitted Date August 23, 2017
First Posted Date August 31, 2017
Last Update Posted Date April 3, 2019
Actual Study Start Date September 4, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2018)
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. ]
The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
Original Primary Outcome Measures
 (submitted: August 29, 2017)
  • 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. ]
    The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
  • Alternative measures of opioid analgesic use [ Time Frame: Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods. ]
    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.
Change History Complete list of historical versions of study NCT03268551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 27, 2018)
  • Alternative measures of opioid analgesic use [ Time Frame: Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods. ]
    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.
  • HIV viral load [ Time Frame: HIV outcomes will be measured seven times every 3 months from baseline through 18 months. ]
    HIV viral load will be measured in copies/ml from blood samples collected during the study.
  • CD4 count [ Time Frame: CD4 count will be measured seven times every 6 months from baseline through 18 months.. ]
    CD4 count will be measured in cells/mm3 from blood samples collected during the study.
  • HIV antiretroviral adherence [ Time Frame: HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months.. ]
    HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.
  • HIV risk behaviors [ Time Frame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months.. ]
    HIV risk behaviors will be a composite measure from self-reported questionnaires.
  • Cannabis use disorder [ Time Frame: Cannabis use disorder will be measured three times every 6 months. ]
    Cannabis use disorder will be measured using standardized instruments.
  • Illicit drug use [ Time Frame: Illicit drug use will be measured seven times every 3 months from baseline through 18 months.. ]
    Illicit drug use will be measured using standardized surveys and urine toxicology testing.
  • Diversion of medical cannabis [ Time Frame: Diversion will be measured seven times every 3 months from baseline through 18 months.. ]
    Diversion will be measured using standardized surveys.
  • Non-fatal overdose [ Time Frame: Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months.. ]
    Non-fatal overdose will be measured using standardized surveys.
  • Death [ Time Frame: Death will be measured 18 months after enrollment. ]
    Death will be ascertained from the National Death Index
  • Accidents/Injuries [ Time Frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months.. ]
    Accidents/Injuries will be measured using standardized survey instruments
Original Secondary Outcome Measures
 (submitted: August 29, 2017)
  • HIV viral load [ Time Frame: HIV outcomes will be measured every 3 months from baseline through 18 months. ]
    HIV viral load will be measured from blood samples collected during the study.
  • CD4 count [ Time Frame: CD4 count will be measured every 6 months from baseline through 18 months. ]
    CD4 count will be measured from blood samples collected during the study.
  • HIV antiretroviral adherence [ Time Frame: HIV antiretroviral adherence will be measured every 3 months from baseline through 18 months. ]
    HIV antiretroviral adherence will be measured from self-reported questionnaires and pharmacy records.
  • HIV risk behaviors [ Time Frame: HIV risk behaviors will be measured every 3 months from baseline through 18 months. ]
    HIV risk behaviors will be measured from self-reported questionnaires.
  • Cannabis use disorder [ Time Frame: Cannabis use disorder will be measured every 6 months from baseline through 18-month follow-up. ]
    Cannabis use disorder will be measured using standardized instruments.
  • Illicit drug use [ Time Frame: Illicit drug use will be measured every 3 months from baseline through 18-month follow-up. ]
    Illicit drug use will be measured using standardized surveys and urine toxicology testing.
  • Diversion of medical cannabis [ Time Frame: Diversion will be measured every 3 months from baseline through 18-month follow-up. ]
    Diversion will be measured using standardized surveys.
  • Non-fatal overdose [ Time Frame: Non-fatal overdose will be measured every 3 months from baseline through 18-month follow-up. ]
    Non-fatal overdose will be measured using standardized surveys.
  • Death [ Time Frame: Death will be measured 18 months after enrollment. ]
    Death will be ascertained from the National Death Index
  • Accidents/Injuries [ Time Frame: Accident/Injuries will be measured every 3 months from baseline through 18-month follow-up. ]
    Accidents/Injuries will be measured using standardized survey instruments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MEMO-Medical Marijuana and Opioids Study
Official Title Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.
Condition
  • Opioid Use
  • Marijuana
  • Chronic Pain
  • HIV/AIDS
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 29, 2017)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chinazo Cunningham, MD,MS 718-920-5971 ccunning@montefiore.org
Contact: Giovanna DiFrancesca 718-920-5763 gcaldero@montefiore.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03268551
Other Study ID Numbers 2017-7857
1R01DA044171-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Chinazo Cunningham, Albert Einstein College of Medicine
Study Sponsor Albert Einstein College of Medicine
Collaborators
  • Fordham University
  • Columbia University
  • National Institute on Drug Abuse (NIDA)
Investigators Not Provided
PRS Account Albert Einstein College of Medicine
Verification Date April 2019