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

Trial Summary

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.

What data supports the effectiveness of the drug THC, Tetrahydrocannabinol, Δ9-THC, Dronabinol, Marinol, Syndros for vaping?

Research indicates that dronabinol, a synthetic form of THC, can help reduce pain intensity and increase satisfaction in patients with chronic pain who are also taking opioids. Additionally, cannabis-based formulations have shown to be a safe and effective option for managing chronic pain, with many patients reporting improvement in symptoms. ^{1 2 3 4 5}

Is vaping cannabis safe for humans?

Vaping cannabis, including THC and its forms like Dronabinol, may carry risks such as lung injuries, seizures, and psychiatric symptoms. While vaping at lower temperatures might produce fewer toxic substances than smoking, the long-term health effects are still unclear, and issues like contamination and mislabeling can pose additional safety concerns. ^{1 6 7 8 9}

How does the drug THC for vaping differ from other treatments?

THC for vaping is unique because it allows for the inhalation of cannabinoids through vapor, which can provide a faster onset of effects compared to oral solutions or pills. This method can be more efficient for therapeutic use as it requires less concentrated cannabinoids and avoids the potential for overheating and contaminants associated with other forms of cannabis consumption. ^{1 7 10 11 12}

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 electronic cigarettes. The study's goals are to test demand for e-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 e-cigarettes and either smoke or vape THC in the laboratory.

Research Team

Dustin Lee, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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 report daily use of e-cigarettes

I have used cannabis through inhalation before.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Old Dog, New Tricks: A Review of Identifying and Addressing Youth Cannabis Vaping in the Pediatric Clinical Setting. [2023]

2. Switzerland 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. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Mapping Literature Review of Medical Cannabis Clinical Outcomes and Quality of Evidence in Approved Conditions in the USA from 2016 to 2019. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Prevalence and correlates of "Vaping" as a route of cannabis administration in medical cannabis patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Drug vaping applied to cannabis: Is "Cannavaping" a therapeutic alternative to marijuana? [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

E-Cigarettes: A Review of New Trends in Cannabis Use. [2022]

10. United States 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]

11. Ireland pubmed.ncbi.nlm.nih.gov

THCVA-A - a new additional marker for illegal cannabis consumption. [2012]

12. United States pubmed.ncbi.nlm.nih.gov

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