NCT02711371

Brief Summary

The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Previous research in cannabis users has predominantly focused on cognitive functions. Moreover, studies have implicated that observed deficits in cannabis users may regenerate after a prolonged abstinence period. Findings might provide important information with respect to relapse vulnerability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

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

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day 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

1.4 years

First QC Date

March 4, 2016

Last Update Submit

February 1, 2017

Conditions

Keywords

addictioncannabisfMRI

Outcome Measures

Primary Outcomes (1)

  • fMRI neural activation patterns of social-emotional brain processes after 28 day abstinence

    Activity patterns in core regions of the emotion processing \& addiction-related brain networks (e.g. striatal regions, insular cortex, prefrontal cortex) will be assessed after 28-days of abstinence. Alterations will be determined by comparison with matched non-drug using controls

    one timepoint = fMRI assessment after 28 day abstinence period

Secondary Outcomes (2)

  • Ratings of subjective experience (pleasantness, rewarding value) will be assessed after 28 days of abstinence

    one timepoint = during fMRI assessment after 28 day abstinence period

  • Relapse interview assessed with Timeline-Followback Method

    one timepoint = 24 months post-fMRI-session

Study Arms (2)

Cannabis Dependence

Cannabis dependent individuals according to DSM 4 criteria, aged 18-40 years

Other: fMRI

Healthy

Healthy controls, socio-demographically matched

Other: fMRI

Interventions

fMRIOTHER
Cannabis DependenceHealthy

Eligibility Criteria

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

Cannabis dependent individuals

You may qualify if:

  • Cannabis dependence according to DSM 4 criteria
  • days of supervised abstinence

You may not qualify if:

  • other DSM 4 diagnosis
  • neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn / Department of Psychiatry

Bonn, North Rhine-Westphalia, 53111, Germany

Location

Related Publications (1)

  • Zimmermann K, Yao S, Heinz M, Zhou F, Dau W, Banger M, Weber B, Hurlemann R, Becker B. Altered orbitofrontal activity and dorsal striatal connectivity during emotion processing in dependent marijuana users after 28 days of abstinence. Psychopharmacology (Berl). 2018 Mar;235(3):849-859. doi: 10.1007/s00213-017-4803-6. Epub 2017 Dec 2.

MeSH Terms

Conditions

Marijuana AbuseBehavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

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.

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 17, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations