Cannabis for Cigarette Smoking

Overseen By Dustin Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Disqualifiers: Illicit drugs, Suicidal behavior, Cardiac arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 visits

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of THC, the active ingredient in cannabis, affect people who smoke cigarettes. Researchers aim to determine how THC influences cravings for cigarettes, mood, heart rate, blood pressure, and overall mental performance. Participants will either smoke or vape THC in a lab setting. The study seeks individuals who regularly use both cigarettes and cannabis, particularly those who experience the effects of smoking daily. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that vaporized THC might pose less risk than smoking it. Studies suggest that vaporizing could expose users to fewer harmful chemicals. However, some cases of sudden lung problems have been linked to vaping.

For smoked THC, research indicates that marijuana joints can deliver more tar to the lungs than tobacco cigarettes of the same weight, potentially increasing the risk of lung issues. Additionally, using marijuana with tobacco could raise the chance of nicotine addiction.

Both methods of using THC carry risks, but effects can vary among individuals. These findings are important to consider for those thinking about joining a trial involving THC. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using THC to help people quit smoking cigarettes because it offers a unique approach compared to standard nicotine replacement therapies and medications like varenicline or bupropion. Unlike these treatments, THC is derived from cannabis and may target the brain's reward system differently, potentially reducing cravings and withdrawal symptoms associated with quitting smoking. Additionally, THC is being tested in different forms, such as vaporized and smoked, which could provide flexibility and potentially faster relief for individuals trying to quit smoking. This novel approach could open new doors for smokers seeking alternative ways to kick the habit.

What evidence suggests that THC might be an effective treatment for cigarette smoking?

This trial will compare the effects of vaporized THC and smoked THC on cigarette smoking habits. Research has shown that THC use, whether through vaping or smoking, can influence cigarette smoking behavior. Some studies suggest that using less cannabis might lead to smoking fewer cigarettes, while other research indicates that using more cannabis could make quitting cigarettes more difficult. THC, whether vaped or smoked, increases heart rate and blood pressure. Additionally, vaping THC might produce stronger effects than smoking it. Although results are mixed, these findings offer insights into how THC might affect cigarette smoking habits. ^{6 7 8 9 10}

Who Is on the Research Team?

Dustin Lee, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• THC

Trial Overview 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.

How Is the Trial Designed?

Group I: Vaporized THC Experimental Treatment 5 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 THC Experimental Treatment 5 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:

Approved in United States as Dronabinol for:

• Appetite loss and weight loss in HIV
• Nausea and vomiting from chemotherapy

Approved in Canada as Dronabinol for:

• Appetite loss and weight loss in HIV/AIDS
• Nausea and vomiting from chemotherapy

Approved in European Union as Dronabinol for:

• Appetite loss and weight loss in HIV/AIDS
• Nausea and vomiting from chemotherapy

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The FDA approved Syndros, an oral solution containing dronabinol (delta-9-THC), on July 1, 2016, indicating its recognized therapeutic use.

Syndros is classified as a Schedule II controlled substance by the DEA, highlighting its potential for abuse but also its medical value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Daily cannabis users show a significantly higher prevalence of cigarette dependence compared to non-daily or non-cannabis users, indicating a potential link between cannabis use and increased cigarette addiction.

From 2002 to 2019, there has been a notable increase in cigarette dependence among both non-daily cannabis users and light to moderate smokers who do not use cannabis, suggesting a growing public health concern regarding smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette dependence is more prevalent and increasing among US adolescents and adults who use cannabis, 2002-2019. Weinberger, AH., Dierker, L., Zhu, J., et al.[2023]

This paper introduces a framework for assessing the safety of additives in cannabis concentrates, aimed at helping regulators and manufacturers without extensive toxicological expertise.

Based on data from over 54,000 users of smart vaporization devices, the study suggests a standard consumption assumption of 100 mg per day for cannabis concentrates to facilitate risk assessments of these additives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates. Vreeke, S., Faulkner, DM., Strongin, RM., et al.[2022]

From 2002 to 2016, the overall prevalence of cannabis use disorder (CUD) decreased, but it significantly increased among non-daily cigarette smokers, indicating a growing concern in this subgroup.

In 2016, CUD was notably more prevalent among non-daily (4.32%) and daily (2.92%) cigarette smokers compared to former (0.99%) and never smokers (1.11%), highlighting the association between cigarette smoking and higher rates of CUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in cannabis use disorder by cigarette smoking status in the United States, 2002-2016. Weinberger, AH., Pacek, LR., Wall, MM., et al.[2019]

In a study of 3787 female twins aged 18-29, cannabis users were found to have a 4.4 times higher risk of progressing from initiating cigarette smoking to regular smoking, and a 2.8 times higher risk of moving from regular smoking to nicotine dependence.

These findings highlight a significant public health concern, as cannabis use may lead to increased rates of cigarette smoking and nicotine dependence, which are associated with high mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions to regular smoking and to nicotine dependence in women using cannabis. Agrawal, A., Madden, PA., Bucholz, KK., et al.[2021]

In a study of 1,145 patients with refractory chronic pain, adding Δ9-tetrahydrocannabinol (dronabinol) to their treatment significantly reduced average pain intensity from 46.3 to 26.8 mm on a visual analog scale over 12 weeks.

Dronabinol was well tolerated, with 46.8% of patients reporting mild drug-related adverse events, and many patients were able to reduce or stop other pain medications during the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ueberall, MA., Horlemann, J., Schuermann, N., et al.[2022]

In a study of 2,112 adult patients with chronic pain, 92.5% reported improvement in their primary symptoms after using cannabis-based oral formulations, indicating high efficacy as an adjuvant treatment.

The majority of patients experienced minimal side effects, with 71.7% reporting none, and the most common mild side effects, such as somnolence and dizziness, tended to decrease over time, suggesting that these formulations are safe for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Moreno-Sanz, G., Madiedo, A., Hernandez, P., et al.[2022]

Clinical studies on cannabis administration are essential for understanding its effects and developing treatments for cannabis dependence, with different methods of administration (smoking, oral, intravenous) each having unique safety and efficacy profiles.

Acute adverse effects from cannabis can include tachycardia, cognitive impairment, and anxiety, necessitating careful screening and monitoring of participants to ensure safety during research studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for clinical research involving cannabis administration. Gorelick, DA., Heishman, SJ.[2019]

The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.

There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. Ware, MA., Tawfik, VL.[2019]

Natural cannabinoids are increasingly used in medical settings and consumer health products, but they carry risks of adverse drug events and interactions due to their complex pharmacology.

Synthetic cannabinoids are more potent than natural ones and can lead to severe reactions, highlighting the need for caution, especially in vulnerable populations at risk for drug-drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural and Synthetic Cannabinoids: Pharmacology, Uses, Adverse Drug Events, and Drug Interactions. Brown, JD., Rivera Rivera, KJ., Hernandez, LYC., et al.[2022]

In 2016, the quit ratios for cigarette smoking were significantly lower among individuals with cannabis use (23%) and cannabis use disorders (CUDs, 15%) compared to those without cannabis use (51% and 48%).

From 2002 to 2016, quit ratios did not improve for individuals with CUDs, highlighting a need for targeted public health strategies to support smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette smoking quit ratios among adults in the USA with cannabis use and cannabis use disorders, 2002-2016. Weinberger, AH., Pacek, LR., Wall, MM., et al.[2021]

Early cannabis use before age 17 is associated with a significantly higher likelihood of developing nicotine dependence, with early users being about twice as likely to report this compared to their co-twins who only experimented with cigarettes.

The increased risk for nicotine dependence in early cannabis users is largely due to shared genetic factors rather than a direct causal relationship between cannabis use and nicotine dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early cannabis use and DSM-IV nicotine dependence: a twin study. Agrawal, A., Lynskey, MT., Pergadia, ML., et al.[2021]

A daily dose of 40 mg of rimonabant for 15 days effectively reduced the physiological effects of smoked cannabis, such as tachycardia, similar to a single higher dose of 90 mg on the first day of treatment.

While the 40 mg dose significantly decreased subjective effects of cannabis on day 8, it did not maintain this effect by day 15, indicating that repeated dosing may not consistently reduce the subjective experience of cannabis effects over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single and multiple doses of rimonabant antagonize acute effects of smoked cannabis in male cannabis users. Huestis, MA., Boyd, SJ., Heishman, SJ., et al.[2019]

In a study involving 30 patients on opioids for chronic pain, dronabinol (synthetic THC) was found to significantly reduce pain intensity and increase treatment satisfaction compared to a placebo, indicating its potential as an effective adjuvant treatment.

The extended Phase II trial showed that titrated doses of dronabinol provided significant pain relief and reduced pain bothersomeness, although side effects were dose-related, suggesting careful monitoring is needed when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. Narang, S., Gibson, D., Wasan, AD., et al.[2013]

Pre-clinical studies indicate that cannabidiol (CBD) may have protective effects against cocaine addiction and toxicity, suggesting a potential therapeutic role for CBD in treating cocaine dependence.

In contrast, human studies show that co-use of cannabis and cocaine often leads to increased harms, with limited evidence from clinical trials supporting the efficacy of cannabinoids in improving cocaine-related treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-exposure of cocaine and cannabinoids and its association with select biological, behavioural and health outcomes: A systematic scoping review of multi-disciplinary studies. Daldegan-Bueno, D., Maia, LO., Glass, M., et al.[2022]

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The link between cannabis and tobacco Young people who use nicotine and cannabis are exposed to negative health effects of both substances – nicotine is highly addictive and can also ...