NCT02801214

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

June 11, 2016

Last Update Submit

February 1, 2017

Conditions

Recreational Cannabis Use

Keywords

cannabisfMRIemotion

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Ratings of subjective experience (affect, craving)

    one time point = during fMRI assessment after 72 hours of abstinence

Study Arms (2)

Recreational Cannabis Use

ages 18-40

Other: fMRI

Healthy control subjects

socio-demographically matched

Other: fMRI

Interventions

fMRIOTHER
Healthy control subjectsRecreational Cannabis Use

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Recreational male cannabis users

You may qualify if:

  • Recreational cannabis use
  • hours of abstinence

You may not qualify if:

  • neurological disorders
  • psychiatric disorders according to DSM-4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. rer. nat. Benjamin Becker

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 15, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02