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Cannabinoid

Genetics and Cannabinoid Response for Cannabis Use Disorder

Phase 1
Waitlist Available
Led By Deepak D'Souza, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-60 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 45 minutes, and 165 minutes after the start of the initial thc/placebo drug infusion.

Summary

This trial focuses on how genetic factors influence a person's vulnerability to cannabis use disorder, psychosis, and cognitive impairment. The study aims to understand how genetics play a role in addiction, response to cannabinoids,

Who is the study for?
This trial is for people aged 18-60 who have used cannabis and may struggle with addiction (CanUD) or have experienced psychosis. It's not for those with major health issues, no history of cannabis use, or pregnant individuals.
What is being tested?
Researchers are testing the effects of Delta-9-THC (the active component in cannabis) against a placebo to understand how genetics influence addiction, response to cannabinoids, and potential treatments for CanUD.
What are the potential side effects?
Delta-9-THC can cause altered senses and mood changes, impaired body movement, difficulty thinking and problem-solving, impaired memory and hallucinations. The severity varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 45 minutes, and 165 minutes after the start of the initial thc/placebo drug infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, 45 minutes, and 165 minutes after the start of the initial thc/placebo drug infusion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician Administered Dissociative Symptoms Scale (CADSS)
CogState Battery
Positive and Negative Symptom Scale (PANSS)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Delta-9-THCActive Control2 Interventions
Active delta-9-THC (0.036 mg/kg) administered intravenously over 20 minutes.
Group II: PlaceboPlacebo Group2 Interventions
Control: small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,333 Total Patients Enrolled
51 Trials studying Schizophrenia
5,167 Patients Enrolled for Schizophrenia
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,443 Total Patients Enrolled
59 Trials studying Schizophrenia
3,804 Patients Enrolled for Schizophrenia
Deepak D'Souza, MDPrincipal InvestigatorYale University
4 Previous Clinical Trials
290 Total Patients Enrolled
1 Trials studying Schizophrenia
170 Patients Enrolled for Schizophrenia
~143 spots leftby Dec 2028
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