Marijuana + Opioid Interaction for Substance Use Disorders
Recruiting in Palo Alto (17 mi)
Overseen byShanna Babalonis, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Shanna Babalonis, PhD
Disqualifiers: Significant medical complications, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What data supports the effectiveness of using marijuana and opioids together for substance use disorders?
Research suggests that marijuana use is associated with lower levels of opioids in the body, which might indicate a potential interaction that could be beneficial in managing opioid dependence. However, the overall impact of cannabis on treatment outcomes for opioid use disorder is unclear, with most studies showing no significant effect.
12345Is the combination of marijuana and opioids generally safe for humans?
There are potential safety concerns when using marijuana, especially THC (the main active ingredient), with other medications, including opioids. THC can interact with drug-metabolizing enzymes, potentially leading to adverse effects, and combining cannabis with other substances can increase the risk of complications, such as cardiac issues.
26789How does the drug Marijuana + Opioid differ from other treatments for substance use disorders?
This drug combination is unique because marijuana use is associated with lower levels of opioids in the body, suggesting it might help reduce opioid dependence and withdrawal symptoms, which is different from traditional treatments that do not involve cannabis.
23101112Eligibility Criteria
This trial is for adults aged 18-50 who have used marijuana and opioids before, are generally healthy, and can stay at the University of Kentucky Hospital research unit for about 6.5 weeks with meals provided. People with significant medical conditions cannot participate.Inclusion Criteria
General good health
Experience with marijuana and opioids
Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided)
+1 more
Exclusion Criteria
Significant medical complications/conditions
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive double-blind administration of intranasal opioid agonist/placebo and vaporized marijuana/placebo to examine drug self-administration
8 weeks
Multiple sessions for drug administration and assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is looking into how marijuana affects the use of oxycodone (a type of opioid) and vice versa. Participants will be given different doses of each drug in a controlled environment to see how one influences the desire or effects of the other.
2Treatment groups
Experimental Treatment
Group I: Double-blind opioid/placebo administrationExperimental Treatment2 Interventions
Participants will receive double-blind administration of intranasal opioid agonist/placebo
Group II: Double-blind marijuana/placebo administrationExperimental Treatment2 Interventions
Participants will receive double-blind administration of vaporized marijuana/placebo
Marijuana is already approved in United States, United States, United States, United States for the following indications:
🇺🇸 Approved in United States as Cannabis for:
- Nausea and vomiting caused by chemotherapy
- Loss of appetite and weight loss associated with HIV/AIDS
- Seizures and epilepsy (specifically Lennox-Gastaut syndrome and Dravet syndrome)
🇺🇸 Approved in United States as Epidiolex for:
- Seizures and epilepsy (specifically Lennox-Gastaut syndrome and Dravet syndrome)
🇺🇸 Approved in United States as Dronabinol (Marinol, Syndros) for:
- Nausea and vomiting caused by chemotherapy
- Loss of appetite and weight loss associated with HIV/AIDS
🇺🇸 Approved in United States as Nabilone (Cesamet) for:
- Nausea and vomiting caused by chemotherapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who Is Running the Clinical Trial?
Shanna Babalonis, PhDLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
The prevalence of Healthcare Effectiveness Data and Information Set (HEDIS) initiation and engagement in treatment among patients with cannabis use disorders in 7 US health systems. [2020]Background: Cannabis use disorders (CUDs) have increased with more individuals using cannabis, yet few receive treatment. Health systems have adopted the Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of initiation and engagement in alcohol and other drug (AOD) dependence treatment, but little is known about the performance of these among patients with CUDs. Methods: This cohort study utilized electronic health records and claims data from 7 health care systems to identify patients with documentation of a new index CUD diagnosis (no AOD diagnosis ≤60 days prior) from International Classification of Diseases, Ninth revision, codes (October 1, 2014, to August 31, 2015). The adjusted prevalence of each outcome (initiation, engagement, and a composite of both) was estimated from generalized linear regression models, across index identification settings (inpatient, emergency department, primary care, addiction treatment, and mental health/psychiatry), AOD comorbidity (patients with CUD only and CUD plus other AOD diagnoses), and patient characteristics. Results: Among 15,202 patients with an index CUD diagnosis, 30.0% (95% confidence interval [CI]: 29.2-30.7%) initiated, 6.9% (95% CI: 6.2-7.7%) engaged among initiated, and 2.1% (95% CI: 1.9-2.3%) overall both initiated and engaged in treatment. The adjusted prevalence of outcomes varied across index identification settings and was highest among patients diagnosed in addiction treatment, with 25.0% (95% CI: 22.5-27.6%) initiated, 40.9% (95% CI: 34.8-47.0%) engaged, and 12.5% (95% CI: 10.0-15.1%) initiated and engaged. The adjusted prevalence of each outcome was generally highest among patients with CUD plus other AOD diagnosis at index diagnosis compared with those with CUD only, overall and across index identification settings, and was lowest among uninsured and older patients. Conclusion: Among patients with a new CUD diagnosis, the proportion meeting HEDIS criteria for initiation and/or engagement in AOD treatment was low and demonstrated variation across index diagnosis settings, AOD comorbidity, and patient characteristics, pointing to opportunities for improvement.
Marijuana use and treatment outcome among opioid-dependent patients. [2019]Information concerning the association between marijuana use and opioid dependence and its treatment is needed to determine effective clinical guidelines for addressing marijuana use among opioid abusers.
Reduced urinary opioid levels from pain management patients associated with marijuana use. [2020]Aim: Marijuana use has been postulated to modulate opioid use, dependence and withdrawal. Broad target drug testing results provide a unique perspective to identify any potential interaction between marijuana use and opioid use. Materials & methods: Using a dataset of approximately 800,000 urine drug test results collected from pain management patients of a time from of multiple years, creatinine corrected opioid levels were evaluated to determine if the presence of the primary marijuana marker 11-nor-carboxy-tetrahydrocannabinol (THC-COOH) was associated with statistical differences in excreted opioid concentrations. Results & conclusion: For each of the opioids investigated (codeine, morphine, hydrocodone, hydromorphone, oxycodone, oxymorphone, fentanyl and buprenorphine), marijuana use was associated with statistically significant lower urinary opiate levels than in samples without indicators of marijuana use.
The relationship between cannabis use and patient outcomes in medication-based treatment of opioid use disorder: A systematic review. [2021]Despite high rates of cannabis use during medication-based treatment of opioid use disorder (MOUD), uncertainty remains around how cannabis influences treatment outcomes. We sought to investigate the relationship between cannabis use during MOUD and a number of patient outcomes. We searched seven databases for original peer-reviewed studies documenting the relationship between cannabis use and at least one primary outcome (opioid use, treatment adherence, or treatment retention) among patients enrolled in methadone-, buprenorphine-, or naltrexone-based therapy for OUD. In total, 41 articles (including 23 methadone, 7 buprenorphine, 6 naltrexone, and 5 mixed modalities) were included in this review. For each primary outcome area, there was a small number of studies that produced findings suggestive of a supportive or detrimental role of concurrent cannabis use, but the majority of studies reported that cannabis use was not statistically significantly associated with the outcome. No studies of naltrexone treatment demonstrated significantly worse outcomes for cannabis users. We identified methodological shortcomings and future research priorities, including exploring the potential role of adjunct cannabis use for improving opioid craving and withdrawal during MOUD. While monitoring for cannabis use may help guide clinicians towards an improved treatment plan, cannabis use is unlikely to independently threaten treatment outcomes.
Association of cannabis use with opioid outcomes among opioid-dependent youth. [2022]Cannabis use is common among opioid-dependent patients, but studies of its association with treatment outcome are mixed. In this secondary analysis, the association of cannabis use with opioid treatment outcome is assessed.
Weeding out the truth: a systematic review and meta-analysis on the transition from cannabis use to opioid use and opioid use disorders, abuse or dependence. [2023]The idea that cannabis is a 'gateway drug' to more harmful substances such as opioids is highly controversial, yet has substantially impacted policy, education and how we conceptualize substance use. Given a rise in access to cannabis products and opioid-related harm, the current study aimed to conduct the first systematic review and meta-analysis on the likelihood of transitioning from cannabis use to subsequent first-time opioid use, opioid use disorders (OUD), dependence or abuse.
Potential Adverse Drug Events with Tetrahydrocannabinol (THC) Due to Drug-Drug Interactions. [2021]Tetrahydrocannabinol (THC) is the primary psychoactive ingredient in cannabis. While the safety of THC and cannabis has been extrapolated from millennia of recreational use, medical marijuana programs have increased exposure among medically complex individuals with comorbid conditions and many co-prescribed medications. Thus, THC should be recognized as a pharmacologically complex compound with potential for drug-drug interactions and adverse drug events. This review summarizes potential adverse drug events related to THC when combined with other medications. Metabolic drug-drug interactions are primarily due to THC conversion by CYP3A4 and CYP2C9, which can be impacted by several common medications. Further, CYP2C9 polymorphisms are highly prevalent in certain racial groups (up to 35% in Caucasians) and increase the bioavailability of THC. THC also has broad interactions with drug-metabolizing enzymes and can enhance adverse effects of other medications. Pharmacodynamic interactions include neurological effects, impact on the cardiovascular system, and risk of infection. General clinical recommendations for THC use include starting with low doses and titrating to desired effects. However, many interactions may be unavoidable, dose-limiting, or a barrier to THC-based therapy. Future work and research must establish sufficient data resources to capture medical marijuana use for such studies. Meanwhile, clinicians should balance the potential risks of THC and cannabis and the lack of strong evidence of efficacy in many conditions with patient desires for alternative therapy.
Cannabinoid Poisoning-Related Emergency Department Visits and Inpatient Hospitalizations in Kentucky, 2017 to 2019. [2023]Background and objectives: Cannabis is the most used federally illicit substance. Due to widespread medicinal use and state-level legalization, public perceptions of cannabis have shifted toward the assumption that cannabis is safe. However, cannabinoids can cause adverse medical complications that may lead people to seek treatment. This study characterized cannabinoid poisoning-related medical encounters, poisoning involving cannabinoids and other psychoactive substances, and cannabinoid poisoning-related cardiac complications. Methods: Administrative billing data for emergency department visits and inpatient hospitalizations in acute care facilities with a discharge date from January 1, 2017 to December 31, 2019 were used to characterize cannabinoid poisoning events in Kentucky, identified by ICD-10-CM diagnosis code T40.7X. Results: There were 1,490 encounters of cannabinoid poisoning; patients were primarily non-Hispanic White males, ages 15-44, who had Medicaid and lived in a metropolitan area. Of those, 31.21% involved poisoning with a second psychoactive substance, primarily stimulants and/or opioids, and 17.72% experienced a cardiac complication. Cannabinoid-polydrug poisoning was associated with inpatient treatment (χ2=199.18, p < 0.001) and cardiac complications (χ2=4.58, p < 0.001). Discussion and Conclusions: These results are consistent with other state-level data. Patients who were diagnosed with cannabis-polydrug poisoning, compared to cannabis alone poisoning, had greater odds of hospital admission and cardiac complications, and longer length of hospital stays. Scientific Significance: The health risks of cannabinoid use must be more broadly recognized, while timely and accurate data need to be shared to guide policies on cannabis access. Future research on cannabinoid poisoning should consider the involvement of other psychoactive drugs.
A Review of Cannabis and Interactions With Anticoagulant and Antiplatelet Agents. [2021]Legalization of medical cannabis has occurred in 33 states and the District of Columbia, and recreational use has increased exponentially since 2013. As a result, it is important to understand how cannabis interacts with other drugs and has potential risks for patients on concomitant medications. Components of medical cannabis can inhibit or compete for several cytochrome P450 (CYP) hepatic isoenzymes, UDP-glucuronosyltransferases, and P-glycoprotein. These enzymes and transporters are involved in the metabolism and absorption of numerous medications, including anticoagulants (ACs) and antiplatelet agents (APs), potentially causing harmful drug-drug interactions. ACs and/or APs are often prescribed to high-risk patients with cardiac conditions, a history of myocardial infarction, or stroke. Cannabis may cause these medications to be less efficacious and put patients at risk for recurrent cardiovascular and cerebrovascular events. Several case reports show cannabis may inhibit the metabolism of warfarin because of CYP2C9 interactions, resulting in increased plasma concentrations, increased international normalized ratio, and risk of bleeding. Cannabidiol inhibits CYP2C19, an isoenzyme responsible for the transformation of clopidogrel to its active thiol metabolite. This interaction could lead to subtherapeutic levels of active metabolite and possibly increased stroke risk. Within this review, a total of 665 articles were screened from PubMed and EMBASE. Four case reports, 1 in vitro study, and 1 pharmacokinetic article were found to be of relevance. This review serves to examine reported and potential cannabis interactions with APs/ACs to help inform patients and health care providers of possible risks and knowledge gaps.
Marijuana users are likely to report opioid misuse among adults over 50 years in representative sample of the United States (2002-2014). [2021]Background: In the wake of the rising rate of prescription opioid misuse, there has been increased public health interest in the possibility that cannabis might help to curb or prevent opioid use disorder. Previous studies were limited to young adult marijuana use population. Little is known about whether in older adult population, marijuana use is associated with a different type of nonmedical use opioids. We examined the association between marijuana use and nonmedical prescription opioids dependence and use among older adults.Methods: The National Survey on Drug Use and Health is a nationally U.S. representative cross-sectional survey. We analyzed data for 75,949 adults aged ≥ 50 who participated in the year 2002-2014.Results: Within the overall population, 3.8% of the older adults reported past-year marijuana use (estimate 3.5 million older adults Americans). Past-year marijuana use was very common (25%-37%) among nonmedical opioid dependence respondents compared to those who did not report nonmedical opioid dependence and use (3.5%-3.7%). Past-year marijuana user was significantly associated with an increase in odds of reporting opioid dependence (AOR 9.6 95% CI = 5.8-15.7), and past-year nonmedical use opioids (AOR 6.4 95% CI = 5.2-7.8). Illicit drug heroin was the most prevalent nonmedical used opioid (AOR 6.3 95% CI = 5.0-7.9), compared to codeine (AOR 4.5 95% CI = 3.5-5.7), hydrocodone (AOR 4.9 95% CI = 3.8-6.4), methadone or tramadol (AOR 4.9 95% CI = 2.0-12.3).Conclusion: Policymakers and healthcare providers should remain mindful that older adult marijuana users regardless of initial legitimate medical needs are likely to report nonmedical opioid use including illicit drug heroin.
Adverse Consequences of Co-Occurring Opioid Use Disorder and Cannabis Use Disorder Compared to Opioid Use Disorder Only. [2022]Background: While there is growing interest in the possibility that cannabis may be a partial substitute for opioids, studies have yet to examine whether individuals with co-occurring opioid and cannabis use disorders (OUD and CUD) have less risk of negative outcomes than those with OUD only. Objective: This study sought to compare the sociodemographic and clinical characteristics of patients diagnosed with co-occurring OUD and CUD to patients with OUD only, CUD only, and patients with any other drug use disorders. We hypothesized that co-occurring OUD and CUD would be associated with lower risk of inpatient admissions and emergency department (ED) visits, lower rates of homelessness, and fewer opioid prescriptions. Methods: Comparisons were based on bivariate analyses, logistic and linear multiple regression models of National Veterans Health Administration (VHA) data from Fiscal Year 2012. Results: Of the 234,181 (94% male) patients diagnosed with drug use disorders, 8.6% were diagnosed with co-occurring OUD and CUD; 33.3% with OUD only; 26.5% with CUD only; and 31.6% with other drug use disorders. Compared to the OUD only group (Mean = 4.8 (SD = 8.84)), the group with co-occurring OUD and CUD was associated with a lower number of opioid prescriptions (Mean = 3.79 (SD = 8.22)) (d = -0.16), but higher likelihood of inpatient psychiatric admission (RR = 1.95) and homelessness (RR = 1.52), and no significant difference in ED visits. Conclusions: These data highlight the need to further investigate whether the complex effects of cannabis use on patients with OUD are counterbalanced by potential benefits of reduced in opioid prescribing.
The Long-Term Relationship Between Cannabis and Heroin Use: An 18- to 20-year Follow-Up of the Australian Treatment Outcome Study (ATOS). [2023]Cannabis use is common among individuals with opioid use disorder, but it remains unclear whether cannabis use is associated with an increase or a reduction in illicit opioid use. To overcome limitations identified in previous longitudinal studies with limited follow-ups, the authors examined a within-person reciprocal relationship between cannabis and heroin use at several follow-ups over 18 to 20 years.