THC for Cannabis Intoxication

(SAGE Trial)

Overseen By Vincent Acebo

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Los Angeles

Must not be taking: Prescription drugs, Herbal supplements

Disqualifiers: Substance use disorder, Psychiatric illness, Hypertension, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 hours per session

103 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

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.

What data supports the effectiveness of the drug Dronabinol for treating cannabis intoxication?

There is no direct evidence from the provided research that supports the effectiveness of Dronabinol for treating cannabis intoxication. However, Dronabinol, a synthetic form of THC, is used for other conditions like appetite stimulation and pain management, which suggests it has some therapeutic effects, but not specifically for cannabis intoxication. ^{1 2 3 4 5}

Is THC generally safe for humans?

THC, the main active ingredient in cannabis, can cause sedation, euphoria, and relaxation, but higher doses may lead to fear, hallucinations, and seizures. Long-term use can affect the lungs and heart and may be linked to mental health issues. Children are more sensitive to cannabis and may experience severe effects like seizures and coma. ^{6 7 8 9 10}

How does the drug Dronabinol differ from other treatments for cannabis intoxication?

Dronabinol, a synthetic form of THC, is unique because it is used to manage symptoms of cannabis intoxication by mimicking the effects of natural THC, potentially helping to stabilize the body's response. Unlike other treatments that may focus on symptom management, Dronabinol directly interacts with the same receptors in the brain as cannabis, offering a novel approach to treatment. ^{2 6 7 11 12}

Research Team

Ziva Cooper, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

Not currently seeking treatment for their cannabis use

I am using effective birth control and am pre-menopausal.

I have used cannabis by smoking or vaping weekly to monthly for the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive smoked and oral THC or placebo to assess effects on abuse liability, intoxication, analgesia, and impairment

6 hours per session

Multiple sessions (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabis
• Dronabinol

Trial Overview The study examines how smoked and oral THC affects people differently based on their age. It looks at potential abuse, intoxication levels, pain relief (analgesia), and impairment in adults grouped as emerging (18-25), middle-aged (35-45), and late middle-aged (55-65).

Participant Groups

Group I: Experimental: Low strength oral THC Experimental Treatment 2 Interventions

Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)

Group II: Experimental: Low strength cannabis Experimental Treatment 2 Interventions

Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)

Group III: Experimental: Higher strength oral THC Experimental Treatment 2 Interventions

Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)

Group IV: Experimental: Higher strength cannabis Experimental Treatment 2 Interventions

Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)

Group V: Placebo Comparator: Placebo Placebo Group 2 Interventions

Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study involving six volunteers, both liquid and capsule forms of THC-containing hemp oils produced plasma THC levels comparable to synthetic THC (dronabinol) used for appetite stimulation, indicating their potential efficacy as dietary supplements.

The study found that THC and its metabolites were detectable in plasma for varying durations, with THCCOOH persisting for up to 39.5 hours after dosing, suggesting a prolonged effect of THC from hemp oils compared to synthetic forms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delta(9)-tetrahydrocannabinol, 11-hydroxy-delta(9)-tetrahydrocannabinol and 11-nor-9-carboxy-delta(9)-tetrahydrocannabinol in human plasma after controlled oral administration of cannabinoids. Goodwin, RS., Gustafson, RA., Barnes, A., et al.[2022]

This study is the first randomized controlled trial to evaluate the effectiveness of dronabinol, a form of Δ9-THC, in reducing opioid consumption in adults with traumatic injuries, involving 122 participants over a 48-hour treatment period.

The trial aims to determine if adding dronabinol to standard pain management can lower the amount of opioids needed, potentially offering a safer alternative for pain relief in acute injury situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. Swartwood, C., Salottolo, K., Madayag, R., et al.[2020]

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]

Two pediatric patients were admitted to the intensive care unit after unintentionally ingesting delta-8 THC products that resembled candy, highlighting the risks associated with these products for children.

While both patients experienced bradypnea and agitation, they were treated with supportive care and discharged after approximately 45 hours, indicating that while delta-8 THC can cause significant symptoms, timely medical intervention can lead to recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional ingestion of putative delta-8 tetrahydrocannabinol by two youth requiring critical care: a case report. Bradley, EK., Hoots, BE., Bradley, ES., et al.[2023]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Cannabinoid1 (CB-1) receptor antagonists: a molecular approach to treating acute cannabinoid overdose. [2021]

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

Delta(9)-tetrahydrocannabinol, 11-hydroxy-delta(9)-tetrahydrocannabinol and 11-nor-9-carboxy-delta(9)-tetrahydrocannabinol in human plasma after controlled oral administration of cannabinoids. [2022]

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

Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. [2020]

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

Cannabis Use Has Negligible Effects Following Severe Traumatic Injury. [2022]

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

Limited Utility of Toxicology Testing at Delivery for Perinatal Cannabis Use. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Acute cannabis toxicity. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

The clinical toxicology of cannabis. [2020]

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

Cannabis Legalization and Acute Harm From High Potency Cannabis Products: A Narrative Review and Recommendations for Public Health. [2020]

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

Cannabis and Cannabinoids: Kinetics and Interactions. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Unintentional ingestion of putative delta-8 tetrahydrocannabinol by two youth requiring critical care: a case report. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Implications of plasma Delta9-tetrahydrocannabinol, 11-hydroxy-THC, and 11-nor-9-carboxy-THC concentrations in chronic cannabis smokers. [2021]