Cannabis for Cigarette Smoking
Recruiting in Palo Alto (17 mi)
Overseen byDustin Lee, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Illicit drugs, Suicidal behavior, Cardiac arrhythmias, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you test positive for illicit drugs other than cannabis and tobacco.
What data supports the effectiveness of the drug THC, Tetrahydrocannabinol, Ξ9-THC, Dronabinol, Marinol, Syndros for cigarette smoking cessation?
Research shows that dronabinol, a form of THC, has been effective in reducing pain and increasing satisfaction in patients with chronic pain, suggesting it may have potential benefits for other conditions. However, there is no direct evidence from the provided studies about its effectiveness for cigarette smoking cessation.
12345Is cannabis generally safe for human use?
Cannabis and its components, like THC, have been used both recreationally and medically, but they can cause side effects such as increased heart rate, low blood pressure, lung irritation (if smoked), and mental effects like anxiety or paranoia. Synthetic THC, like dronabinol, is considered safer due to its slower onset and lower potency, but caution is advised, especially for people with heart, lung, or mental health issues.
678910How does the drug THC differ from other treatments for cigarette smoking?
THC (Tetrahydrocannabinol) is unique because it is primarily known for its psychoactive effects and is being explored for its potential to help with cigarette smoking, which is not a standard use. Unlike traditional nicotine replacement therapies, THC works by interacting with the brain's cannabinoid receptors, which may influence smoking behavior differently.
1112131415Eligibility Criteria
This trial is for individuals who regularly use tobacco and cannabis. Participants should be willing to smoke or vape THC in a lab setting. The study excludes those with certain health conditions, but specific exclusion criteria are not listed.Inclusion Criteria
I am willing to use effective birth control during the study.
I am 21 or older and not currently seeking any medical treatment.
I smoke tobacco cigarettes every day.
+4 more
Exclusion Criteria
Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding
I have a history of serious heart rhythm problems or vasospastic disease.
I plan to cut down or quit smoking or using cannabis soon.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive multiple doses of THC and placebo to assess the impact on cigarette use behavior
6 visits
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study examines the effects of different doses of THC (5mg, 30mg, and a placebo with no THC) on cigarette smokers' behavior, cravings, mood changes, heart rate, blood pressure, lung function via breath carbon monoxide levels and thinking skills.
2Treatment groups
Experimental Treatment
Group I: Vaporized THCExperimental Treatment5 Interventions
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
Group II: Smoked THCExperimental Treatment5 Interventions
Each participant in this arm will receive 0, 5, and 30mg of THC over the course of six visits. Each participant will also receive combustible cigarettes containing 0.03mg and 0.80mg of nicotine.
THC is already approved in United States, Canada, European Union for the following indications:
πΊπΈ Approved in United States as Dronabinol for:
- Appetite loss and weight loss in HIV
- Nausea and vomiting from chemotherapy
π¨π¦ Approved in Canada as Dronabinol for:
- Appetite loss and weight loss in HIV/AIDS
- Nausea and vomiting from chemotherapy
πͺπΊ Approved in European Union as Dronabinol for:
- Appetite loss and weight loss in HIV/AIDS
- Nausea and vomiting from chemotherapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins University Behavioral Pharmacology Research UnitBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users. [2019]A single 90-mg dose of the cannabinoid CB1 receptor antagonist rimonabant attenuates effects of smoked cannabis in humans.
Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. [2013]We assessed the efficacy of dronabinol (Marinol capsules; Solvay Pharmaceuticals, Brussels, Belgium), a synthetic Delta(9)-THC (tetrahydrocannabinol), in 30 patients taking opioids for chronic pain to determine its potential analgesic effects as an adjuvant treatment. Phase I of this 2-phase study was a randomized, single-dose, double-blinded, placebo-controlled, crossover trial in which subjects were randomly administered either 10 mg or 20 mg of dronabinol or identical placebo capsules over the course of three, 8-hour visits. Baseline self-report measures, hourly ratings of pain intensity, pain relief, pain bothersomeness, treatment satisfaction, mood, side effects, and blood serum levels were obtained. Phase II was an extended open-label titrated trial of dronabinol as add-on medication to patients on stable doses of opioids. Results of the Phase I study showed that patients who received dronabinol experienced decreased pain intensity and increased satisfaction compared with placebo. No differences in benefit were found between the 20 mg and 10 mg doses. In the Phase II trial, titrated dronabinol contributed to significant relief of pain, reduced pain bothersomeness, and increased satisfaction compared with baseline. The incidence of side effects was dose-related. Overall, the use of dronabinol was found to result in additional analgesia among patients taking opioids for chronic noncancer pain.
Effectiveness and Tolerability of Dronabinol Use in Patients with Chronic Pain: A Retrospective Analysis of 12-Week Open-Label Real-World Data Provided by the German Pain e-Registry. [2022]To evaluate the effectiveness of Ξ9-tetrahydrocannabinol (dronabinol [DRO]) as an add-on treatment in patients with refractory chronic pain (CP).
Co-exposure of cocaine and cannabinoids and its association with select biological, behavioural and health outcomes: A systematic scoping review of multi-disciplinary studies. [2022]Cocaine use entails severe health- and social-related harms globally. Treatment options for cocaine dependence are highly limited. Benefits of cannabinoids for addiction have been documented, making it opportune to examine existing data on the possible outcomes associated with cannabinoids and cocaine co-use. We conducted a systematic scoping review following the PRISMA guidelines of peer-reviewed, English-language studies published from 2000 to 2021 in four databases (Medline, Web-of-Science, CINAHL Plus, and PsycInfo), assessing the co-exposure of cannabis/cannabinoids with cocaine on behavioural, biological or health outcomes. Both quantitative and qualitative, as well as humans and pre-clinical animals' studies (n=46) were included. Pre-clinical studies (n=19) showed mostly protective effects of cannabidiol (CBD) administration on animal models of addiction (e.g., cocaine-craving, -relapse, and -withdrawal) and cocaine-toxicity. Tetrahydrocannabinol (THC) had more inconsistent results, with both protective and counter-protective effects. Human studies (n=27) were more heterogeneous and assessed natural ongoing cannabis and cocaine use or dependence. Quantitative-based studies showed mostly enhanced harms in several outcomes (e.g., cocaine use, mental health); two available clinical trials found no effect upon CBD administration on cocaine-related treatment outcomes. Qualitative data-based studies reported cannabis use as a substitute for or to alleviate harms of crack-cocaine use. While pre-clinical studies suggest a potential of cannabinoids, especially CBD, to treat cocaine addiction, the few trials conducted in humans found no benefits. Cannabis co-use by cocaine users commonly presents a risk factor, entailing enhanced harms for users. More rigorous, controlled trials are still necessary to investigate cannabinoids' potential considering pre-clinical findings and reported benefits from specific drug users.
Sex-Dependent Prescription Patterns and Clinical Outcomes Associated With the Use of Two Oral Cannabis Formulations in the Multimodal Management of Chronic Pain Patients in Colombia. [2022]To date, the therapeutic use of cannabinoids in chronic pain management remains controversial owing to the limited clinical evidence found in randomized clinical trials (RCTs), the heterogeneous nature of the clinical indication, and the broad range of cannabis-based medicinal products (CBMPs) used in both experimental and observational clinical studies. Here we evaluate patient-reported clinical outcomes (PROMS) in a cohort of adult patients, diagnosed with chronic pain of diverse etiology, who received adjuvant treatment with oral, cannabis-based, magistral formulations between May and September 2021 at the Latin American Institute of Neurology and Nervous System (ILANS-Zerenia) in Bogotá, Colombia. During this period, 2,112 patients completed a PROMS questionnaire aimed at capturing the degree of clinical improvement of their primary symptom and any potential side effects. Most participants were female (76.1%) with an average age of 58.7 years old, and 92.5% (1,955 patients) reported some improvement in their primary symptom (p < 0.001). Two monovarietal, full-spectrum, cannabis formulations containing either cannabidiol (CBD 30 mg/mL; THC <2 mg/mL) or a balanced composition (THC 12 mg/mL; CBD 14 mg/mL) accounted for more than 99% of all prescriptions (59.5 and 39.8%, respectively). The degree of improvement was similar between both formulations, although males reported less effectiveness in the first 4 weeks of treatment. Sex-specific differences were also found in prescription patterns, with male patients increasing the intake of the balanced chemotype overtime. For many patients (71.7%) there were no adverse side effects associated to the treatment and those most reported were mild, such as somnolence (13.0%), dizziness (8.1%) and dry mouth (4.2%), which also appeared to fade over time. Our results constitute the first real-world evidence on the clinical use of medicinal cannabis in Colombia and suggest that cannabis-based oral magistral formulations represent a safe and efficacious adjuvant therapeutic option in the management of chronic pain.
Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans- tetrahydrocannabinol (delta-9-THC)] in Schedule II. Final rule. [2018]This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.
Methods for clinical research involving cannabis administration. [2019]Better scientific understanding of cannabis effects and the development of treatments for cannabis dependence require clinical studies involving cannabis administration. Cannabis can be administered by smoking a plant-derived cigarette or by oral or intravenous administration of delta9-tetrahydrocannabinol (THC), the primary psychoactive chemical in cannabis. The smoked route is most commonly used outside the laboratory, but is subject to wide variation in absorbed dose. Oral synthetic THC is a legally marketed medication (dronabinol), also subject to wide pharmacokinetic variation, but offering a greater safety margin because of slower onset of action and lower potency. Intravenous THC offers precise investigator control of dose and timing. Acute adverse effects of cannabis administration include tachycardia, orthostatic hypotension, pulmonary irritation (if smoked), motor incoordination, cognitive impairment, anxiety, paranoia, and psychosis. Screening of research subjects should identify and exclude those with risk factors for such events, e.g., a history of significant cardiovascular, pulmonary, or psychiatric disorders. Monitoring of subjects during cannabis administration should include heart rate, blood pressure, and mental status. Subjects should not be discharged from research participation until reevaluation has shown that they have returned to baseline status.
Safety issues concerning the medical use of cannabis and cannabinoids. [2019]Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.
Natural and Synthetic Cannabinoids: Pharmacology, Uses, Adverse Drug Events, and Drug Interactions. [2022]The purpose of this narrative review is to describe the current use environment of both natural and synthetic cannabinoids while providing context for cannabinoid chemistry and pharmacology. In addition to a long history of recreational and nonmedical use, natural cannabinoids are increasingly used as prescription products, through medical cannabis programs, and as consumer health products. Despite anecdotal safety evidence, cannabis and cannabinoids are pharmacologically complex and pose risks for adverse drug events and drug-drug interactions. Synthetic cannabinoids, particularly agonists of cannabinoid receptors, are more potent than natural cannabinoids and can lead to more severe reactions and medical emergencies. This review provides a summary of approved uses and an overview of mechanisms of action for adverse drug events with natural and synthetic cannabinoids. Clinical considerations for special populations that may be at heightened risk for drug-drug interactions and adverse drug events while using natural or synthetic cannabinoids are examined, and recommendations are provided.
A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates. [2022]Vaporization is an increasingly prevalent means to consume cannabis, but there is little guidance for manufacturers or regulators to evaluate additive safety. This paper presents a first-tier framework for regulators and cannabis manufacturers without significant toxicological expertise to conduct risk assessments and prioritize additives in cannabis concentrates for acceptance, elimination, or further evaluation. Cannabinoids and contaminants (e.g., solvents, pesticides, etc.) are excluded from this framework because of the complexity involved in their assessment; theirs would not be a first-tier toxicological assessment. Further, several U.S. state regulators have provided guidance for major cannabinoids and contaminants. Toxicological risk assessment of cannabis concentrate additives, like other types of risk assessment, includes hazard assessment, dose-response, exposure assessment, and risk characterization steps. Scarce consumption data has made exposure assessment of cannabis concentrates difficult and variable. Previously unpublished consumption data collected from over 54,000 smart vaporization devices show that 50th and 95th percentile users consume 5 and 57 mg per day on average, respectively. Based on these and published data, we propose assuming 100 mg per day cannabis concentrate consumption for first-tier risk assessment purposes. Herein, we provide regulators, cannabis manufacturers, and consumers a preliminary methodology to evaluate the health risks of cannabis concentrate additives.
Cigarette smoking quit ratios among adults in the USA with cannabis use and cannabis use disorders, 2002-2016. [2021]The prevalence of cigarette smoking is nearly three times higher among persons who use cannabis and have cannabis use disorders (CUDs), relative to those who do not. The current study examined cigarette quit ratios from 2002 to 2016 among US adults with and without cannabis use and CUDs.
Cigarette dependence is more prevalent and increasing among US adolescents and adults who use cannabis, 2002-2019. [2023]Cannabis use is increasing among cigarette smokers. If cannabis use is associated with cigarette dependence, a barrier to smoking cessation, this could have public health implications for tobacco control. The current study estimated the prevalence of cigarette dependence among US individuals who smoke cigarettes by cannabis use status, and investigated trends in cigarette dependence from 2002 to 2019 among cigarette smokers by cannabis use status and cigarette consumption (ie, cigarettes per day, CPD).
Early cannabis use and DSM-IV nicotine dependence: a twin study. [2021]Evidence suggests that cannabis users are at increased risk for cigarette smoking--if so, this may potentially be the single most alarming public health challenge posed by cannabis use. We examine whether cannabis use prior to age 17 years is associated with an increased likelihood of DSM-IV nicotine dependence and the extent to which genetic and environmental factors contribute to this association.
Trends in cannabis use disorder by cigarette smoking status in the United States, 2002-2016. [2019]Cannabis use is on the rise in the United States (US) and is disproportionately common among cigarette smokers. Cannabis use disorder (CUD) occurs among a small subset of cannabis users and may impact cigarette use. The objective of this study was to estimate trends in the prevalence of CUD among daily, non-daily, former, and never cigarette smokers from 2002 to 2016.
Transitions to regular smoking and to nicotine dependence in women using cannabis. [2021]While there is substantial support in the literature for an increased prevalence of cannabis use in cigarette smokers, emerging studies allude to the possibility that cannabis users may, in turn, be at significantly elevated risk for rapid transitions in their cigarette smoking trajectories. If there is evidence in its favor, the increased rates of cigarette smoking in cannabis users may prove to be the most significant public health problem associated with cannabis use.