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Recruiting EARLY_Phase 1 NCT05472818

SV2A Density Cannabis Use Disorder

Trial Parameters

Condition Cannabis Use Disorder
Sponsor Yale University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 51
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-04-12
Completion 2027-05-30
Interventions
[11C]APP311

Brief Summary

The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal \[11C\]APP-311/\[11C\]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal \[11C\]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.

Eligibility Criteria

CUD Participants Inclusion Criteria: 1. Able to provide informed consent 2. Male and female 18-75 years old 3. Daily cannabis use 4. Positive urine screen for cannabinoids and negative for all other drugs on 5. Diagnosis of DSM-5 cannabis use disorder (≥ moderate, i.e., ≥ 4 \[of 11\] symptoms). 6. Must express a willingness at screening to set a date to attempt to quit using cannabis. 7. Physically healthy i.e., no clinically unstable medical conditions. 8. For women of childbearing potential (WOCBP) and men, willingness to practice birth control and to inform study staff immediately if either they (for women) or their partner (for men) becomes pregnant. 9. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study. CUD Participants Exclusion Criteria: 1. Laboratory tests with clinically significant abnormalities or positive urine toxicology screen with exception of cannabinoids. 2. Women with a positive pregnancy test or women wh

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