Dataset Information

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.

ABSTRACT:

Introduction

In the USA, opioid analgesic use and overdoses have increased dramatically. One rapidly expanding strategy to manage chronic pain in the context of this epidemic is medical cannabis. Cannabis has analgesic effects, but it also has potential adverse effects. Further, its impact on opioid analgesic use is not well studied. Managing pain in people living with HIV is particularly challenging, given the high prevalence of opioid analgesic and cannabis use. This study's overarching goal is to understand how medical cannabis use affects opioid analgesic use, with attention to ?9-tetrahydrocannabinol and cannabidiol content, HIV outcomes and adverse events.

Methods and analyses

We are conducting a cohort study of 250 adults with and without HIV infection with (a) severe or chronic pain, (b) current opioid use and (c) who are newly certified for medical cannabis in New York. Over 18 months, we collect data via in-person visits every 3?months and web-based questionnaires every 2?weeks. Data sources include: questionnaires; medical, pharmacy and Prescription Monitoring Program records; urine and blood samples; and physical function tests. Using marginal structural models and comparisons within participants' 2-week time periods (unit of analysis), we will examine how medical cannabis use (primary exposure) affects (1) opioid analgesic use (primary outcome), (2) HIV outcomes (HIV viral load, CD4 count, antiretroviral adherence, HIV risk behaviours) and (3) adverse events (cannabis use disorder, illicit drug use, diversion, overdose/deaths, accidents/injuries, acute care utilisation).

Ethics and dissemination

This study is approved by the Montefiore Medical Center/Albert Einstein College of Medicine institutional review board. Findings will be disseminated through conferences, peer-reviewed publications and meetings with medical cannabis stakeholders.

Trial registration number

ClinicalTrials.gov Registry (NCT03268551); Pre-results.

SUBMITTER: Cunningham CO

PROVIDER: S-EPMC7778768 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Cunningham Chinazo O CO Starrels Joanna L JL Zhang Chenshu C Bachhuber Marcus A MA Sohler Nancy L NL Levin Frances R FR Minami Haruka H Slawek Deepika E DE Arnsten Julia H JH

BMJ open 20201229 12

<h4>Introduction</h4>In the USA, opioid analgesic use and overdoses have increased dramatically. One rapidly expanding strategy to manage chronic pain in the context of this epidemic is medical cannabis. Cannabis has analgesic effects, but it also has potential adverse effects. Further, its impact on opioid analgesic use is not well studied. Managing pain in people living with HIV is particularly challenging, given the high prevalence of opioid analgesic and cannabis use. This study's overarchin ...[more]

PMID: 33376181

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Project description:OBJECTIVE:To determine the association of medical marijuana legalization with prescription opioid utilization. METHODS:A 10% sample of a nationally representative database of commercially insured population was used to gather information on opioid use, chronic opioid use, and high-risk opioid use for the years 2006-2014. Adults with pharmacy and medical benefits for the entire calendar year were included in the population for that year. Multilevel logistic regression analysis, controlling for patient, person-year, and state-level factors, were used to determine the impact of medical marijuana legalization on the three opioid use measures. Sub-group analysis among cancer-free adults and cancer-free adults with at least one chronic non-cancer pain condition in the particular year were conducted. Alternate regression models were used to test the robustness of our results including a fixed effects model, an alternate definition for start date for medical marijuana legalization, a person-level analysis, and a falsification test. RESULTS:The final sample included a total of 4,840,562 persons translating into 15,705,562 person years. Medical marijuana legalization was found to be associated with a lower odds of any opioid use: OR = 0.95 (0.94-0.96), chronic opioid use: OR = 0.93 (0.91-0.95), and high-risk opioid use: OR = 0.96 (0.94-0.98). The findings were similar in both the sub-group analyses and all the sensitivity analyses. The falsification tests showed no association between medical marijuana legalization and prescriptions for antihyperlipidemics (OR = 1.00; CI 0.99-1.01) or antihypertensives (OR = 1.00; CI 0.99-1.01). CONCLUSIONS:In states where marijuana is available through medical channels, a modestly lower rate of opioid and high-risk opioid prescribing was observed. Policy makers could consider medical marijuana legalization as a tool that may modestly reduce chronic and high-risk opioid use. However, further research assessing risk versus benefits of medical marijuana legalization and head to head comparisons of marijuana versus opioids for pain management is required.

Project description:ImportanceOver the last 25 years, illicit cannabis use and cannabis use disorders have increased among US adults, and 28 states have passed medical marijuana laws (MML). Little is known about MML and adult illicit cannabis use or cannabis use disorders considered over time.ObjectiveTo present national data on state MML and degree of change in the prevalence of cannabis use and disorders.Design, participants, and settingDifferences in the degree of change between those living in MML states and other states were examined using 3 cross-sectional US adult surveys: the National Longitudinal Alcohol Epidemiologic Survey (NLAES; 1991-1992), the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC; 2001-2002), and the National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III; 2012-2013). Early-MML states passed MML between NLAES and NESARC ("earlier period"). Late-MML states passed MML between NESARC and NESARC-III ("later period").Main outcomes and measuresPast-year illicit cannabis use and DSM-IV cannabis use disorder.ResultsOverall, from 1991-1992 to 2012-2013, illicit cannabis use increased significantly more in states that passed MML than in other states (1.4-percentage point more; SE, 0.5; P = .004), as did cannabis use disorders (0.7-percentage point more; SE, 0.3; P = .03). In the earlier period, illicit cannabis use and disorders decreased similarly in non-MML states and in California (where prevalence was much higher to start with). In contrast, in remaining early-MML states, the prevalence of use and disorders increased. Remaining early-MML and non-MML states differed significantly for use (by 2.5 percentage points; SE, 0.9; P = .004) and disorder (1.1 percentage points; SE, 0.5; P = .02). In the later period, illicit use increased by the following percentage points: never-MML states, 3.5 (SE, 0.5); California, 5.3 (SE, 1.0); Colorado, 7.0 (SE, 1.6); other early-MML states, 2.6 (SE, 0.9); and late-MML states, 5.1 (SE, 0.8). Compared with never-MML states, increases in use were significantly greater in late-MML states (1.6-percentage point more; SE, 0.6; P = .01), California (1.8-percentage point more; SE, 0.9; P = .04), and Colorado (3.5-percentage point more; SE, 1.5; P = .03). Increases in cannabis use disorder, which was less prevalent, were smaller but followed similar patterns descriptively, with change greater than never-MML states in California (1.0-percentage point more; SE, 0.5; P = .06) and Colorado (1.6-percentage point more; SE, 0.8; P = .04).Conclusions and relevanceMedical marijuana laws appear to have contributed to increased prevalence of illicit cannabis use and cannabis use disorders. State-specific policy changes may also have played a role. While medical marijuana may help some, cannabis-related health consequences associated with changes in state marijuana laws should receive consideration by health care professionals and the public.

Project description:Most US states have passed medical marijuana laws (MMLs), with great variation in program regulation impacting enrollment rates. We aimed to compare changes in rates of marijuana use, heavy use and cannabis use disorder across age groups while accounting for whether states enacted medicalized (highly regulated) or non-medical mml programs.Difference-in-differences estimates with time-varying state-level MML coded by program type (medicalized versus non-medical). Multi-level linear regression models adjusted for state-level random effects and covariates as well as historical trends in use.Nation-wide cross-sectional survey data from the US National Survey of Drug Use and Health (NSDUH) restricted use data portal aggregated at the state level.Participants comprised 2004-13 NSDUH respondents (n ~ 67?500/year); age groups 12-17, 18-25 and 26+ years. States had implemented eight medicalized and 15 non-medical MML programs.Primary outcome measures included (1) active (past-month) marijuana use; (2) heavy use (> 300 days/year); and (3) cannabis use disorder diagnosis, based on DSM-IV criteria. Covariates included program type, age group and state-level characteristics throughout the study period.Adults 26+ years of age living in states with non-medical MML programs increased past-month marijuana use 1.46% (from 4.13 to 6.59%, P = 0.01), skewing towards greater heavy marijuana by 2.36% (from 14.94 to 17.30, P = 0.09) after MMLs were enacted. However, no associated increase in the prevalence of cannabis use disorder was found during the study period. Our findings do not show increases in prevalence of marijuana use among adults in states with medicalized MML programs. Additionally, there were no increases in adolescent or young adult marijuana outcomes following MML passage, irrespective of program type.Non-medical marijuana laws enacted in US states are associated with increased marijuana use, but only among adults aged 26+ years. Researchers and policymakers should consider program regulation and subgroup characteristics (i.e. demographics) when assessing for population level outcomes. Researchers and policymakers should consider program regulation and subgroup characteristics (i.e. demographics) when assessing for population level outcomes.

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Project description:BackgroundDespite repeated calls by medical associations to gather evidence on the harms and benefits of cannabis, there are ongoing methodological challenges to conducting observational and clinical studies on cannabis, including a high rate of patients that are lost to follow-up (LTFU). This study explores factors potentially associated with retention in a large prospective study of Canadian medical cannabis patients, with the goal of reducing the probability that patients will be lost to follow-up in future cannabis research.MethodsThe Tilray Observational Patient Study (TOPS) was a multi-site, prospective study assessing the impact of medical cannabis over 6 months in a broad population of authorized Canadian cannabis patients. The study took place from 2016 to 19, and we conducted a series of exploratory analyses including a Kaplan-Meier survival analysis and logistic regressions to assess the potential association between study retention and variables including patient characteristics, cannabis and prescription drug use, quality of life, and the legalization of non-medical cannabis.ResultsOverall, 1011 participants were included in this analysis, contributing 287 patient-years of data. Retention was 728 (72%) at 3 months, and 419 (41.4%) at 6 months. Our analyses found significantly lower adjusted odds of retention following legalization (AOR 0.28, 95% CI 0.18-0.41), and in patients that used prescription opioids at baseline (AOR 0.62, 95% CI 0.46-0.85), while increased odds of retention were found in patients with a higher baseline psychological score (AOR 1.43, 95% CI 1.08-1.90) or that used anti-seizure medications at baseline (AOR 1.91, 95% CI 1.30-2.81).DiscussionTOPS provided a unique opportunity to examine patient characteristics and other variables that may be associated with retention in prospective medical cannabis studies. Our findings highlight some of the challenges of conducting medical cannabis research at a time when patients have a multitude of cannabis access options, including legal adult dispensaries and a robust illicit market. High LTFU rates can impact the validity of studies, and potentially lead to misestimations of the harms and benefits of medical cannabis use. Despite being a multi-site prospective study, this was a convenience sample, thereby limiting the generalizability of these findings. Additionally, data regarding the use of cannabis was self-reported by patients, so is subject to potential recall bias.ConclusionWe found evidence that external policy changes that affect access to cannabis such as the legalization of non-medical adult use and patient characteristics associated with patient physical/psychological capacity can impact retention in prospective medical cannabis studies. Evidence-based strategies to reduce study burden on participants, such as minimizing in-person visits by providing digitized internet-based surveys and phone or telemedicine follow-up options as well as ensuring adequate participant compensation could improve retention. Additionally, policy-related changes aimed at improving access to medical cannabis, including increased cost-coverage and community-based distribution, could encourage patients to remain in the federal medical cannabis program and thereby reduce LTFU in associated studies.

Dataset Information

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.

Introduction

Methods and analyses

Ethics and dissemination

Trial registration number

Publications

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.

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