RECRUITING

SV2A Density Cannabis Use Disorder

Conditions

Cannabis Use Disorder Healthy Cannabis Use Disorder (CUD)Healthy subjects synaptic vesicle density [11C]APP311 UCB-J

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

SV2A Density Cannabis Use Disorder

Quick Facts

Study Start:2022-05-01

Study Completion:2032-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05472818

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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 who are lactating. 3. Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field 4. Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits. 5. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) Subjects who have donated blood within 8 weeks of the present study 6. Medications that could alter synaptic density and, therefore, confound the interpretation of study data. 7. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

Inclusion Criteria

Exclusion 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.

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 who are lactating.
3. Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
4. Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
5. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) Subjects who have donated blood within 8 weeks of the present study
6. Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
7. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

Contacts and Locations

Study Contact

Anika Kumar

CONTACT

(203) 974-7525

anika.kumar@yale.edu

Principal Investigator

Deepak C D'Souza

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University School of Medicine

New Haven, Connecticut, 06511

United States

Collaborators and Investigators

Sponsor: Yale University

Deepak C D'Souza, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-01

Study Completion Date2032-05

Study Record Updates

Study Start Date2022-05-01

Study Completion Date2032-05

Terms related to this study

Keywords Provided by Researchers

Cannabis Use Disorder (CUD)
Healthy subjects
synaptic vesicle density
[11C]APP311
UCB-J

Additional Relevant MeSH Terms

Cannabis Use Disorder
Healthy