Emotional Brain Processes in Recreational Cannabis Users | NCT02801214

Studies
Emotional Brain Processes in Recreational Cannabis Users

NCT02801214

Sponsor

University of Electronic Science and Technology of China

Status

Completed

Last Update Posted

Feb 2, 2017Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Recreational Cannabis Use

Interventions

fMRI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jun 11, 2016

First Submission Date that Met QC Criteria

Jun 11, 2016

First Posted Date

Jun 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2017

Last Update Posted Date

Feb 2, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Becker, Prof. Dr. rer. nat. Benjamin Becker, University of Electronic Science and Technology of ChinaPrincipal Investigator

Lead Sponsor

University of Electronic Science and Technology of ChinaOTHER

Collaborators

Name	Class
German Research Foundation	OTHER
University Hospital, Bonn	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This fMRI study investigates neural correlates of emotion regulation, emotion processing and craving in recreational cannabis users.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Recreational Cannabis Use		ages 18-40	Other: fMRI
Healthy control subjects		socio-demographically matched	Other: fMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI	Other		Healthy control subjects Recreational Cannabis Use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fMRI neural correlates of emotional brain processes in recreational cannabis users after 72 hours of abstinence	Activation patterns in brain regions known to be involved in emotional processing and to be altered by cannabis use (e.g. striatum, prefrontal cortex, insula, ACC)	one time point = fMRI assessment after 72 hours of abstinence

Secondary Outcomes

Measure	Description	Time Frame
Ratings of subjective experience (affect, craving)		one time point = during fMRI assessment after 72 hours of abstinence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recreational cannabis use
72 hours of abstinence

Exclusion Criteria:

neurological disorders
psychiatric disorders according to DSM-4

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Recreational male cannabis users

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided