NCT03268551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

August 23, 2017

Last Update Submit

November 7, 2023

Conditions

Opioid UseMarijuanaChronic PainHIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Alternative measures of opioid analgesic use

    Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.

  • HIV viral load

    HIV outcomes will be measured seven times every 3 months from baseline through 18 months.

  • CD4 count

    CD4 count will be measured seven times every 6 months from baseline through 18 months..

  • HIV antiretroviral adherence

    HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..

  • HIV risk behaviors

    HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Health System

The Bronx, New York, 10451, United States

Location

Vireo Health

White Plains, New York, 10601, United States

Location

Related Publications (2)

  • Zhang C, Slawek DE, Ross J, Zolotov Y, Castillo F, Levin FR, Sohler NL, Minami H, Cunningham CO, Starrels JL, Arnsten JH. Factors Associated with Medical Cannabis Use After Certification: A Three-Month Longitudinal Study. Cannabis Cannabinoid Res. 2024 Jun;9(3):e859-e869. doi: 10.1089/can.2022.0248. Epub 2023 Mar 24.

    PMID: 36961410DERIVED

  • Cunningham CO, Starrels JL, Zhang C, Bachhuber MA, Sohler NL, Levin FR, Minami H, Slawek DE, Arnsten JH. Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic pain. BMJ Open. 2020 Dec 29;10(12):e043400. doi: 10.1136/bmjopen-2020-043400.

    PMID: 33376181DERIVED

Related Links

MeSH Terms

Conditions

Marijuana AbuseChronic PainAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 31, 2017

Study Start

September 4, 2018

Primary Completion

July 14, 2023

Study Completion

July 14, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

US(2)