NCT02801422

Brief Summary

The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 1, 2016

Completed
4 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
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

3.1 years

First QC Date

June 11, 2016

Last Update Submit

October 26, 2018

Conditions

Keywords

cannabisfMRIaddictionrelapse

Outcome Measures

Primary Outcomes (1)

  • fMRI neural activation patterns of emotional processing

    Activation patterns associated with emotion processing, emotion regulation, craving and stress are determined in addicted cannabis users compared to non-using matched control subjects

    one time point = fMRI assessment after minimum 24 hours of abstinence

Secondary Outcomes (1)

  • Timeline Followback Interviews

    one time point = 12 months after fMRI data acquisition

Study Arms (2)

Cannabis Dependence

ages 18-40

Other: fMRI

Healthy control subjects

socio-demographically matched

Other: fMRI

Interventions

fMRIOTHER
Cannabis DependenceHealthy control subjects

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
  • hours abstinence

You may not qualify if:

  • other DSM-4 diagnosis
  • neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn

Bonn, North Rhine Westfalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Marijuana AbuseBehavior, AddictiveRecurrence

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin Becker, PhD

CONTACT

Kaeli Zimmermann, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
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

February 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations