This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

German Research Foundation

University Hospital, Bonn

Information provided by (Responsible Party):

Benjamin Becker, University of Electronic Science and Technology of China

ClinicalTrials.gov Identifier:

NCT02711371

First received: March 4, 2016

Last updated: March 13, 2016

Last verified: March 2016

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.

Cannabis Dependence Other: fMRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long-term Effects of Cannabis Use on Social and Emotional Brain Processes in Dependent Cannabis Users After a 28 Day Abstinence Period

Primary Outcome Measures:

  • fMRI neural activation patterns of social-emotional brain processes after 28 day abstinence [ Time Frame: one timepoint = fMRI assessment after 28 day abstinence period ] [ Designated as safety issue: No ]

    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

Secondary Outcome Measures:

  • Ratings of subjective experience (pleasantness, rewarding value) will be assessed after 28 days of abstinence [ Time Frame: one timepoint = during fMRI assessment after 28 day abstinence period ] [ Designated as safety issue: No ]

    Self-reported ratings of pleasantness & rewarding value during soft-pleasant touch.

  • Relapse interview assessed with Timeline-Followback Method [ Time Frame: one timepoint = 24 months post-fMRI-session ] [ Designated as safety issue: No ]

    Association between fMRI neural correlates and drug use during follow up period as predictor of relapse

Estimated Enrollment: 50
Study Start Date: July 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Cannabis Dependence

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

Other: fMRI
Healthy

Healthy controls, socio-demographically matched

Other: fMRI

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Cannabis dependent individuals

Inclusion Criteria:

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

Exclusion Criteria:

  • other DSM 4 diagnosis
  • neurological disorders

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No Contacts or Locations Provided

Responsible Party: Benjamin Becker, Prof. Dr. rer. nat., University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT02711371     History of Changes
Other Study ID Numbers: ART_Can_01 
Study First Received: March 4, 2016
Last Updated: March 13, 2016
Health Authority: Germany: Ethics Board University of Bonn

Keywords provided by University of Electronic Science and Technology of China:

addiction
cannabis
fMRI

Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 13, 2016