Cannabis Concentrates for THC Intake

(THC Titration Trial)

Overseen By Victor Tang, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must not be taking: THC, CBD

Disqualifiers: Pregnancy, Cardiac issues, Psychotic disorders, Neurological illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 hours per session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular cannabis users can control their THC intake when using high-potency cannabis concentrates. Researchers will test THC levels of 30%, 60%, and 90% to assess their effects on users' cognitive function, physical responses, and potential for addiction. The trial is designed for individuals who use cannabis regularly (1-4 times a week) and have experience with vaping high-potency concentrates. Participants will help evaluate whether people can naturally limit their THC consumption and how different potencies affect health and behavior. Insights from this trial could inform future cannabis policies and consumer awareness. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that may shape future cannabis use guidelines.

Will I have to stop taking my current medications?

The trial requires participants to abstain from any drugs not medically required and specifically excludes those taking prescribed medications that contain THC or CBD. If your current medications do not contain THC or CBD and are medically necessary, you may not need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that strong cannabis can pose some risks. Studies have found it might lead to issues like addiction, known as cannabis use disorder, and cognitive difficulties. Some individuals might also experience anxiety or paranoia.

Regarding safety, researchers are studying cannabis concentrates with THC levels of 30%, 60%, and 90% to better understand their effects. Evidence suggests that higher THC levels can cause stronger effects, but the exact safety of each level remains under investigation. High THC levels have been linked to potential health risks, such as changes in the brain, but more research is needed to fully understand these effects.

For those considering participation in a trial with these cannabis concentrates, it is important to know that safety information is still being collected, especially for the higher THC levels. Consulting a healthcare professional can help in understanding the potential risks and benefits based on personal health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-potency cannabis concentrates because they represent a unique approach to THC intake. Unlike traditional cannabis products, which often vary in THC concentration, these liquid concentrates offer precise dosing with concentrations of 30%, 60%, and 90% THC. This level of control can potentially lead to more predictable effects and improved management of symptoms, such as pain or anxiety, compared to smoking or edibles. Additionally, the liquid form allows for alternative consumption methods, which might appeal to those who prefer not to smoke. These features could make cannabis concentrates a promising option for individuals seeking more tailored cannabis therapy.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of different THC concentrations in cannabis concentrates. Research has shown that high-potency cannabis concentrates, with THC levels of 30%, 60%, and 90%, can increase health risks. Studies have found that these high THC products are more likely to lead to issues such as cannabis use disorder and psychosis. Even when individuals attempt to control their intake to manage the effects, they often consume more THC overall. This can result in stronger effects on cognitive and bodily functions. While lower THC levels might cause fewer problems, higher doses can raise the risk of negative reactions and long-term health issues. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for regular cannabis users, both male and female, who are interested in how different THC concentrations affect them. Participants must be able to vape cannabis and should not have conditions that exclude them from safely participating.

Inclusion Criteria

My high blood pressure is under control.

Abstain from recreational drugs for at least 48 hours prior to each visit

I agree not to drive for 24 hours after each clinic visit.

Exclusion Criteria

I am taking medications that contain THC or CBD.

Participation in another clinical or non-therapeutic study in the last three months

I have had recent open heart or chest surgery, or cataract surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a randomized crossover trial to evaluate self-titration of THC dose when vaping cannabis concentrates of different potencies (30%, 60%, and 90% THC).

4 hours per session

Multiple sessions with intervals for different potencies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive and physiological assessments.

4 weeks

Exploratory Analysis

Exploration of sex differences in titration efficiency, cognitive impairment, and physiological effects.

What Are the Treatments Tested in This Trial?

Interventions

• High-Potency Cannabis Concentrates

Trial Overview The study tests if people can adjust their intake when using high-THC cannabis concentrates (30%, 60%, 90%) to control the effects they feel. It's a randomized crossover trial comparing subjective experiences, cognitive impacts, and THC levels in blood.

How Is the Trial Designed?

Group I: Liquid Cannabis Concentrate (90% THC) Experimental Treatment 1 Intervention

Group II: Liquid Cannabis Concentrate (60% THC) Experimental Treatment 1 Intervention

Group III: Liquid Cannabis Concentrate (30% THC) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6312155/

The Problem with the Current High Potency THC Marijuana ... They found that use of high potency THC >15% resulted in a three times increased risk of psychosis, and if the use was daily there was a five times increased ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07105449

THC Titration of High-Potency Cannabis Concentrates High-potency cannabis use is associated with public health risks, such as cannabis use disorder, psychotic disorders, and impaired cognition ...

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20240269

High-Potency Cannabis Use and Health: A Systematic ... A recent review covered observational studies on certain nonacute mental health outcomes, including anxiety, depression, psychosis, and cannabis ...

4. ajph.aphapublications.org ajph.aphapublications.org/doi/10.2105/AJPH.2023.307414

Health Effects of High-Concentration Cannabis Products Fifty-four studies (12%) examined a direct association between cannabis concentrates and a health outcome, whereas 189 (42%) examined a direct ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460323000126

Adult use of highly-potent Δ9-THC cannabis concentrate ... A 2016 Twitter-based adult survey found an overall prevalence of 48% with lifetime concentrate use41, which was more likely among those in RCL ...

6. phi.org phi.org/thought-leadership/report-and-recommendations-of-the-high-potency-cannabis-think-tank-to-the-state-of-california/

Report and Recommendations of the High Potency ... Prohibit the sale of liquid or solid concentrates for inhalation (e.g. dabs, wax, shatter) with THC content above 60% and implement careful ...

7. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.2023.307414

Scoping Review and Evidence Map | AJPH We included studies that reported THC concentration for a cannabis product taken by any route or that reported a product description (e.g., “ ...

8. medicine.yale.edu medicine.yale.edu/news-article/not-your-grandmothers-marijuana-rising-thc-concentrations-in-cannabis-can-pose-devastating-health-risks/

Marijuana: Rising THC Concentrations in Cannabis Can Pose ... Marijuana: Rising THC Concentrations in Cannabis Can Pose Health Risks. Brain changes and other cannabis side effects need more study, say Yale ...