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CB1R in Synthetic Psychoactive Cannabinoids (CB1R in Spice)

Primary Purpose

Drug Dependence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
[11-C]OMAR
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Drug Dependence focused on measuring K2, Spice, Synthetic Marijuana

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion:

  • Able to provide written consent
  • Age 18-55
  • Current Synthetic Psychoactive Cannabinoids consumption

Exclusion:

  • MRI metal exclusions and claustrophobia
  • Education completed is less than 12 years

Sites / Locations

  • Connecticut Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Synthetic Psychoactive Cannabinoid Users

Arm Description

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

Outcomes

Primary Outcome Measures

Positron Emission Tomography (PET Imaging)
CB1R availability using [11-C]OMAR PET imaging Change in CB1R availability (e.g. volume distribution).

Secondary Outcome Measures

CogState Battery
2. Changes in Cognition during withdrawal using a computerized battery Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.
Electroencephalogram
3. Changes in brain rhythms measured by Electroencephalography Changes in electroencephalographic (EEG) brain rhythms related to information processing.

Full Information

First Posted
March 6, 2018
Last Updated
August 9, 2023
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03539575
Brief Title
CB1R in Synthetic Psychoactive Cannabinoids
Acronym
CB1R in Spice
Official Title
CB1R Availability in Synthetic Psychoactive Cannabinoid Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Dependence
Keywords
K2, Spice, Synthetic Marijuana

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synthetic Psychoactive Cannabinoid Users
Arm Type
Other
Arm Description
Synthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer [11-C]OMAR.
Intervention Type
Other
Intervention Name(s)
[11-C]OMAR
Intervention Description
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
Primary Outcome Measure Information:
Title
Positron Emission Tomography (PET Imaging)
Description
CB1R availability using [11-C]OMAR PET imaging Change in CB1R availability (e.g. volume distribution).
Time Frame
Change in CB1R availability from baseline throughout one test day
Secondary Outcome Measure Information:
Title
CogState Battery
Description
2. Changes in Cognition during withdrawal using a computerized battery Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.
Time Frame
Change in CB1R availability from baseline throughout one test day
Title
Electroencephalogram
Description
3. Changes in brain rhythms measured by Electroencephalography Changes in electroencephalographic (EEG) brain rhythms related to information processing.
Time Frame
Change in CB1R availability from baseline throughout one test day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: Able to provide written consent Age 18-55 Current Synthetic Psychoactive Cannabinoids consumption Exclusion: MRI metal exclusions and claustrophobia Education completed is less than 12 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepak C D'Souza, M.D.
Phone
203-932-5711
Ext
2594
Email
deepak.dsouza@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Skosnik, Ph.D.
Phone
203-932-5711
Ext
2252
Email
patrick.skosnik@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak C D'Souza, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohini Ranganathan, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick D Skosnik, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-974-7775
Phone
203-974-7540
First Name & Middle Initial & Last Name & Degree
Deepak C D'Souza, M.D.
First Name & Middle Initial & Last Name & Degree
Mohini Ranganathan, M.D.
First Name & Middle Initial & Last Name & Degree
Patrick D Skosnik, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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CB1R in Synthetic Psychoactive Cannabinoids

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