Synthetic Cannabinoids for Substance Use Disorders

(CB1R in Spice Trial)

Overseen By Deepak C D'Souza, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Mri metal, Claustrophobia, Education, others

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

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated.

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

The trial information does not specify whether you need to stop taking your current medications.

Is the use of synthetic cannabinoids generally safe in humans?

Synthetic cannabinoids can be dangerous and have been linked to serious health issues like psychosis, mania, and even death. Reports from emergency departments and case studies show that these drugs can cause significant harm, including mental health problems and physical injuries. ^{1 2 3 4 5}

Research Team

Deepak C D'Souza, M.D.

Principal Investigator

Yale University

Mohini Ranganathan, M.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults aged 18-55 who currently use synthetic psychoactive cannabinoids and can give written consent. It's not suitable for individuals with less than a high school education or those who cannot undergo MRI due to metal in their body or fear of enclosed spaces.

Inclusion Criteria

Able to provide written consent

Current Synthetic Psychoactive Cannabinoids consumption

Exclusion Criteria

MRI metal exclusions and claustrophobia

Education completed is less than 12 years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Cognitive Testing

Participants undergo PET imaging and cognitive testing to assess CB1R availability and cognitive functions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and testing

4 weeks

Treatment Details

Interventions

• [11-C]OMAR

Trial Overview [11-C]OMAR, a substance used in imaging studies, is being tested to see if it shows lower CB1R availability in the brains of people using synthetic psychoactive cannabinoids compared to non-users.

Participant Groups

Group I: Synthetic Psychoactive Cannabinoid Users Experimental Treatment 1 Intervention

Synthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer \[11-C\]OMAR.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Pharmacology, Toxicology, and Adverse Effects of Synthetic Cannabinoid Drugs. [2022]

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

Hospitalisation associated with use of the synthetic cannabinoid K2. [2019]

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

Synthetic Cathinone and Cannabinoid Designer Drugs Pose a Major Risk for Public Health. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The 12-month prevalence and nature of adverse experiences resulting in emergency medical presentations associated with the use of synthetic cannabinoid products. [2013]

5. Ireland pubmed.ncbi.nlm.nih.gov

Synthetic cannabinoid use among patients in residential substance use disorder treatment: prevalence, motives, and correlates. [2021]