Cannabis for Vaping

Overseen By Dustin Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Illicit drugs

Disqualifiers: Substance use disorder, 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 examines how different doses of THC, the active ingredient in cannabis, affect people who use e-cigarettes. Researchers aim to understand THC's impact on cravings, mood, heart rate, and other physical responses. Participants will try both smoked and vaporized THC in a controlled setting. This trial suits healthy adults who use e-cigarettes daily and consume cannabis at least once a week. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this 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 must not have a substance use disorder other than alcohol, cannabis, or nicotine, and you cannot 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 has shown some safety concerns with both smoked and vaporized THC (tetrahydrocannabinol). For vaporized THC, studies have found that although it may release fewer harmful chemicals than smoking, it has been linked to lung injuries. Additionally, insufficient long-term safety information about THC vaping products makes their safety uncertain.

For smoked THC, common side effects include red eyes, dry mouth, and drowsiness. It can also affect memory and cause anxiety. Long-term use might lead to cannabinoid hyperemesis syndrome, which causes severe nausea and vomiting.

Both smoked and vaporized THC can alter mood, thoughts, and perception. Some individuals might handle these effects well, while others might not. Consider these factors carefully when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore a new way of delivering THC for potential therapeutic benefits, using both smoked and vaporized methods. Unlike traditional oral or topical cannabis treatments, these methods allow THC to be absorbed more rapidly through the lungs, which might lead to quicker effects. Additionally, the combination of THC with varying nicotine levels in e-cigarettes could offer insights into how these substances interact, potentially leading to more personalized and effective treatment options. This approach could open up new avenues for managing conditions that respond to THC, offering a fresh perspective on cannabis-based therapies.

What evidence suggests that this trial's treatments could be effective for e-cigarette users?

This trial will compare the effects of smoked THC with vaporized THC. Research has shown that vaping THC can produce stronger effects than smoking it. For instance, one study found that people who vaped a 25-milligram dose of THC experienced stronger effects on average than those who smoked the same amount. Both smoking and vaping THC can increase heart rate and blood pressure. Vaping typically results in higher levels of THC in the blood, leading to more noticeable effects. These findings suggest that both methods can significantly impact sensations and the body's response. ^{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 use e-cigarettes and smoke or vape THC. Participants must be willing to try different doses of THC in a controlled lab setting. Specific eligibility criteria are not provided, but typically include age range, health status, and frequency of cannabis and tobacco use.

Inclusion Criteria

Must have biological confirmation of cannabis use: positive urinary THC drug test at screening

Must report daily use of e-cigarettes

I have used cannabis through inhalation before.

Exclusion Criteria

Must meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine

Must report current intention to reduce or quit cannabis or tobacco use within the next 30 days

Must have a positive breath alcohol test at study admission

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 effects on e-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 how various doses of THC (high dose, low dose, no THC) affect the desire for e-cigarettes with full nicotine or placebo nicotine. It measures cravings, mood changes, heart rate, blood pressure, 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 e-cigarette containing 0% and 5.0% 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 e-cigarette containing 0% and 5.0% 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 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]

A survey of delta-8-THC consumers revealed that over half (51%) use it to treat various health conditions, with anxiety and stress being the most common, suggesting potential therapeutic benefits.

Participants reported favorably comparing delta-8-THC to delta-9-THC and pharmaceutical drugs, indicating it may have similar efficacy with potentially fewer adverse effects, although knowledge about safe dosages and medical integration remains low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer Experiences with Delta-8-THC: Medical Use, Pharmaceutical Substitution, and Comparisons with Delta-9-THC. Kruger, DJ., Kruger, JS.[2023]

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

Following FDA approval, the DEA classified Syndros as a Schedule II controlled substance, reflecting its potential for abuse but also its accepted medical use in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments. [2017]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6324384/

Acute Effects of Smoked and Vaporized Cannabis in Healthy ... Vaporized cannabis resulted in qualitatively stronger drug effects for most pharmacodynamic outcomes and higher peak concentrations of THC in ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038913

Smoking or Vaping Cannabis and Cardiovascular Function An area of particular interest is the relationship between cannabis use, cardiovascular function, and cardiovascular disease in general.

3. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2018/12/vaping-cannabis-produces-stronger-effects-than-smoking-cannabis-for-infrequent-users

Vaping Cannabis Produces Stronger Effects Than Smoking ... Results showed that a few minutes after smoking, those who vaped the 25-milligram THC dosage reported an average of 77.5 on the overall strength ...

4. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00147-3/fulltext

Adolescent Cannabis Vaping Trends (2021–2023): Delta-9 ... The results revealed a significant, marked increase in the self-reported vaping of THC, CBD, and SCs among U.S. middle- and high-school students ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2716984

Smoked vs Vaporized Cannabis The higher dose of 25 mg of THC resulted in 21 and 15 significant outcomes for vaporized and smoked cannabis, respectively. ... effects of THC, ...

6. nida.nih.gov nida.nih.gov/research-topics/cannabis-marijuana

Cannabis (Marijuana) | National Institute on Drug Abuse (NIDA) Cannabis products with THC can cause changes in mood, thoughts, and perceptions of reality. These products can also cause harmful health effects ...

7. en.wikipedia.org en.wikipedia.org/wiki/Tetrahydrocannabinol

Tetrahydrocannabinol Side effects include red eyes, dry mouth, drowsiness, memory impairment, anxiety, and, with chronic use, cannabinoid hyperemesis syndrome. While human overdose ...

8. cdc.gov cdc.gov/cannabis/faq/index.html

Cannabis Frequently Asked Questions THCA is not psychoactive. However, when THCA is exposed to heat, such as through smoking, vaping, or dabbing, it converts into THC, which is ...

9. samhsa.gov samhsa.gov/substance-use/learn/marijuana/risks

Know the Effects, Risks and Side Effects of Marijuana Research shows that people who use marijuana are more likely to have relationship problems, worse educational outcomes, lower career achievement, and reduced ...

10. fda.gov fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

What to Know About Products Containing Cannabis and CBD The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.