NCT03539575

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
May 2018Dec 2026

First Submitted

Initial submission to the registry

March 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

8.6 years

First QC Date

March 6, 2018

Last Update Submit

April 23, 2026

Conditions

Drug Dependence

Keywords

K2SpiceSynthetic Marijuana

Outcome Measures

Primary Outcomes (1)

  • Positron Emission Tomography (PET Imaging)

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

    Change in CB1R availability from baseline throughout one test day

Secondary Outcomes (2)

  • CogState Battery

    Change in CB1R availability from baseline throughout one test day

  • Electroencephalogram

    Change in CB1R availability from baseline throughout one test day

Study Arms (1)

Synthetic Psychoactive Cannabinoid Users

OTHER

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

Other: [11-C]OMAR

Interventions

[11-C]OMAROTHER

The radiotracer, \[11-C\]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Synthetic Psychoactive Cannabinoid Users

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Education completed is less than 12 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Deepak C D'Souza, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

  • Mohini Ranganathan, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 6, 2018

First Posted

May 29, 2018

Study Start

May 1, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)