What side effects are associated with this type of intervention?

Common treatments involving cannabis, such as THC, CBD, and nabiximols, are associated with several side effects. These include somnolence (drowsiness), dizziness, and impaired concentration. In clinical trials, cannabinoids have shown a higher risk of adverse events compared to placebo, with somnolence and dizziness being particularly notable. Other reported side effects include confusion, anxiety, paresthesias (tingling sensations), and mood changes. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of cannabis-based treatments.

What prior FDA approvals exist?

The FDA has approved several cannabis-based treatments that interact with the endocannabinoid system. Notably, Epidiolex, which contains cannabidiol (CBD), is approved for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. Additionally, Marinol (dronabinol) and Cesamet (nabilone), which contain synthetic THC, are approved for treating nausea and vomiting associated with chemotherapy and for appetite stimulation in AIDS patients. These approvals highlight the therapeutic potential of cannabinoids in managing specific medical conditions.

What other types of research exist?

Promising novel alternatives to cannabinoids for patients considering treatment in 2024 include: <ol> <li>Endocannabinoid Modulators: These drugs aim to enhance the body's own endocannabinoid system without the psychotropic effects of cannabis.</li> <li>Selective Cannabinoid Receptor Agonists: These target specific cannabinoid receptors to provide pain relief and other benefits without broad activation of the endocannabinoid system.</li> <li>Non-Cannabinoid Analgesics: New classes of pain relievers that do not interact with the endocannabinoid system but offer effective pain management, such as novel opioids with reduced addiction potential or non-opioid pain relievers targeting different pain pathways.</li> <li>Biologics and Gene Therapy: Advanced treatments that can modulate pain and inflammation at the genetic or molecular level, offering long-term relief without the side effects of traditional medications.</li> </ol>

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Cannabinoid

Inhaled THC for Cannabis Response Differences by Gender (THC-Gender-II Trial)

Phase 1

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and +80 minutes after start of oral dronabinol administration.

Summary

This trial examines how inhaling THC affects women compared to men and explores why these differences might exist.

Who is the study for?

This trial is for healthy men and women who have tried cannabis at least once. It's not suitable for those who've never used cannabis or are currently dealing with major stress.

What is being tested?

The study is looking into how inhaled THC (the active ingredient in cannabis) affects men and women differently by comparing it to a placebo, which has no active ingredients.

What are the potential side effects?

While the side effects aren't listed, typical reactions to THC may include altered senses, mood changes, difficulty with thinking and problem-solving, impaired memory, and occasionally anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and +80 minutes after start of oral dronabinol administration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and +80 minutes after start of oral dronabinol administration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and +80 minutes after start of oral dronabinol administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)

Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Delta-9-Tetrahydrocannabinol (THC)Active Control1 Intervention

4 mg vaporized THC will be administered.

Group II: PlaceboPlacebo Group1 Intervention

Inhaled placebo (no active cannabinoids)

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cannabis treatments primarily interact with the endocannabinoid system, which includes CB1 and CB2 receptors, endogenous cannabinoids, and related enzymes. THC binds to CB1 receptors in the brain, producing psychoactive effects and pain relief, while CBD modulates THC's effects and interacts with other receptors like serotonin and TRPV1. Understanding these mechanisms is crucial for patients as it affects the therapeutic benefits and side effects of cannabis, impacting its use in managing chronic pain, multiple sclerosis, and cancer-related symptoms.

Cannabinoid pharmacology.Understanding Cannabis sativa L.: Current Status of Propagation, Use, Legalization, and Haploid-Inducer-Mediated Genetic Engineering.