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Trial record 19 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

The Neural Correlates of Cannabis Use (Multimodal)

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ClinicalTrials.gov Identifier: NCT03104257
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. This research will also examine associations between CB1R availability, neural oscillations and cognitive function.

Condition or disease Intervention/treatment
Cannabis Dependence Healthy Other: [11-C]OMAR

Detailed Description:
The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed outpatient abstinence (confirmed by tracking creatinine adjusted urine THC-COOH levels). This research will also examine associations between CB1R availability, neural oscillations and cognitive function using [11-C]OMAR PET imaging and electroencephalography.

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Study Type : Observational
Estimated Enrollment : 37 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Neural Correlates of Cannabis Use
Study Start Date : December 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Group/Cohort Intervention/treatment
Cannabis Dependent Subjects
Subjects who are frequent cannabis users
Other: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.

Healthy Controls
Subjects with no current cannabis use
Other: [11-C]OMAR
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.




Primary Outcome Measures :
  1. CB1R availability using [11-C]OMAR PET imaging [ Time Frame: Change in CB1R availability from baseline to 48 hours and 28 days ]
    Change in CB1R availability (e.g. volume distribution).


Secondary Outcome Measures :
  1. Changes in Cognition during withdrawal using a computerized battery [ Time Frame: Change in CB1R availability from baseline to 48 hours and 28 days ]
    Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.

  2. Changes in brain rhythms measured by Electroencephalography [ Time Frame: Change in CB1R availability from baseline to 48 hours and 28 days ]
    Changes in electroencephalographic (EEG) brain rhythms related to information processing.


Biospecimen Retention:   Samples With DNA
When specimens and information are stored, researchers are careful to try to protect your identity from discovery by others. Samples and information will receive a unique code. Other researchers will only receive coded samples and information, and will not be able to link the code to subjects. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Research subjects can be both cannabis-using or non-cannabis using males and females between the ages of 18-65.
Criteria

Inclusion Criteria: Cannabis Dependent Subjects

  • Current cannabis consumption
  • Willing to abstain from cannabis use for four weeks

Inclusion Criteria for Healthy Controls

  • No current cannabis consumption

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104257


Contacts
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Contact: Patrick Skosnik, PhD 203-932-5711 ext 2252 patrick.skosnik@yale.edu
Contact: Mohini Ranganathan, MD 203-932-5711 ext 2546 mohini.ranganathan@yale.edu

Locations
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United States, Connecticut
Conneticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact    203-974-7775      
Contact    203-974-7489      
Principal Investigator: Patrick Skosnik, PhD         
Principal Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Patrick Skosnik, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03104257     History of Changes
Other Study ID Numbers: 1308012514
1R01DA040698-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yale University:
Healthy Control, Cannabis, Dependence

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders