40 Participants Needed

Dronabinol Effects Related to Cannabis Use

(THC-Gender-I Trial)

LT
CL
CH
MR
Overseen ByMohini Ranganathan, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Yale University
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking estrogen supplements or oral contraceptive pills.

What evidence supports the effectiveness of the drug Dronabinol?

Dronabinol, a form of THC, has shown potential benefits in managing symptoms like pain, spasticity, and appetite loss in conditions such as chronic pain, multiple sclerosis, and cancer. Studies indicate that while it can cause side effects like dizziness and dry mouth, many patients report symptom improvement, suggesting it can be an effective treatment option.12345

Is Dronabinol generally safe for human use?

Dronabinol, a cannabis-derived medicine, is generally considered to have a low risk profile with common side effects like dizziness and mood changes. Serious complications are rare, but it can affect heart rate and blood pressure, and may not be safe for people with heart issues or during pregnancy.678910

How is the drug Dronabinol different from other treatments for cannabis use?

Dronabinol, which contains delta9-tetrahydrocannabinol (THC), is unique because it acts on the cannabinoid system in the brain, specifically targeting CB1 and CB2 receptors, which can help manage symptoms like nausea and appetite loss. Unlike other treatments, it can be administered orally and has a well-documented profile for treating conditions like nausea from chemotherapy and appetite issues in HIV/AIDS patients.1112131415

What is the purpose of this trial?

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Eligibility Criteria

This trial is for healthy men and women who have tried cannabis at least once. Women must not be taking estrogen supplements or oral contraceptives, and participants with a sesame oil allergy cannot join. Those under major stress recently or currently are also excluded.

Inclusion Criteria

I am in good physical and mental health.
At least one lifetime exposure to cannabis

Exclusion Criteria

I am currently taking estrogen supplements or oral contraceptive pills.
Sesame oil allergy
Cannabis naive individuals
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of 10 mg Dronabinol or placebo and are monitored for acute effects

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Dronabinol
  • Placebo
Trial Overview The study aims to understand how cannabinoids affect men and women differently by comparing the effects of Dronabinol (a synthetic form of THC) to a placebo in healthy individuals.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: THCActive Control1 Intervention
10 mg Dronabinol will be administered orally.
Group II: PlaceboPlacebo Group1 Intervention
Placebo pill (no active cannabinoids).

Dronabinol is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Marinol for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting
  • Sleep apnea
🇺🇸
Approved in United States as Syndros for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting
🇨🇦
Approved in Canada as REDUVO for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Findings from Research

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.
Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.
The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials.Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]
In a survey of 10,010 patients in Germany, dronabinol was the most commonly prescribed cannabis-based medicine (65%), primarily for treating pain (73%), with side effects like tiredness and dizziness being consistent with known profiles of cannabis products.
Patients using cannabis flowers were generally younger and more likely to be male, with different treatment patterns and diagnoses compared to those using other cannabis medicines, indicating a need for careful monitoring and reporting in this group.
[Three years of cannabis as medicine-preliminary results of the survey accompanying the prescription of medical cannabis in Germany].Schmidt-Wolf, G., Cremer-Schaeffer, P.[2021]
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.
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]

References

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. [2022]
[Three years of cannabis as medicine-preliminary results of the survey accompanying the prescription of medical cannabis in Germany]. [2021]
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]
Cannabinoids in medicine: A review of their therapeutic potential. [2022]
The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. [2022]
Consumer Experiences with Delta-8-THC: Medical Use, Pharmaceutical Substitution, and Comparisons with Delta-9-THC. [2023]
The pharmacologic and clinical effects of medical cannabis. [2022]
[A review of side effects and complications with cannabinoid treatment]. [2006]
Dronabinol and marijuana in HIV(+) marijuana smokers: acute effects on caloric intake and mood. [2022]
Cardiovascular Complications of Marijuana and Related Substances: A Review. [2020]
The good and the bad effects of (-) trans-delta-9-tetrahydrocannabinol (Delta 9-THC) on humans. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Bronchial effects of aerosolized delta 9-tetrahydrocannabinol in healthy and asthmatic subjects. [2013]
Reinforcing effects of oral Delta9-THC in male marijuana smokers in a laboratory choice procedure. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
The effects of cannabinoids on body temperature and brain catecholamine synthesis. [2013]
Complex pharmacology of natural cannabinoids: evidence for partial agonist activity of delta9-tetrahydrocannabinol and antagonist activity of cannabidiol on rat brain cannabinoid receptors. [2019]
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