THC for Cannabis Intoxication
(SAGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different forms of THC, both smoked and oral, affect potential misuse, feelings of being high, pain relief, and impairment based on age. Participants will receive either a placebo or varying strengths of cannabis or oral THC, such as Dronabinol, a synthetic form of THC, to help understand these effects. The trial seeks adults aged 18-65 who regularly use cannabis (at least weekly) and have not experienced serious issues with it. Those not seeking cannabis treatment and without adverse reactions to it may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or regular over-the-counter medications, except for hormonal contraceptives and hormone replacement therapy, to participate in this trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cannabis and THC (the active ingredient in cannabis) have been studied for safety in humans. For low-strength cannabis (10 mg THC), short-term effects can include coordination problems, muscle weakness, and fatigue, as seen in various studies. These effects are temporary but can be unpleasant.
For higher-strength cannabis (20 mg THC), studies indicate that stronger doses can lead to more serious effects, such as an increased risk of mental health issues, especially with frequent use. While higher doses might be safe for some, they can pose risks for others.
Low-strength oral THC (10 mg) is generally well-tolerated. Research on dronabinol, a synthetic form of THC, has shown it can alleviate symptoms like nausea and loss of appetite, with few side effects at low doses.
Higher-strength oral THC (20 mg) can affect memory and concentration. Some users may feel more intoxicated, but it is usually safe if doses are managed carefully.
Overall, cannabis and THC are generally considered safe for most adults in controlled amounts. However, side effects can vary based on the dose and individual reactions. It's important to understand how your body responds and to start with lower doses if uncertain.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for cannabis intoxication, which often involves supportive care and benzodiazepines, this trial explores the effects of both smoked and oral THC to manage the condition. Researchers are excited because these treatments use THC itself, either smoked or in pill form, to potentially counteract over-intoxication by engaging the same cannabinoid receptors in a controlled way. This approach could offer a more targeted response by modulating the endocannabinoid system directly, potentially leading to quicker and more effective symptom relief.
What evidence suggests that this trial's treatments could be effective for cannabis intoxication?
Research shows that THC, the main active ingredient in cannabis, affects people differently depending on the dose. In this trial, participants may receive low-strength smoked cannabis, which studies have found can increase heart rate and cause a moderate "high." Another group will receive stronger smoked cannabis, usually leading to a more intense high and greater enjoyment. Additionally, some participants will receive low or high doses of oral THC. Studies suggest that both low and high doses of oral THC can effectively reduce pain and increase pain tolerance. High doses of oral THC can also improve mood and reduce cravings for cannabis. Overall, these findings suggest THC influences the intensity of the high and its effectiveness in relieving pain.678910
Who Is on the Research Team?
Ziva Cooper, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for males and non-pregnant females aged 18-65 who use cannabis weekly to monthly, primarily by inhalation, over the last 6 months. They should not be seeking treatment for cannabis use, have no significant adverse effects from it, and must have a BMI of 18.5-34kg/m2. Women must use effective birth control if pre-menopausal.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive smoked and oral THC or placebo to assess effects on abuse liability, intoxication, analgesia, and impairment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabis
- Dronabinol
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator