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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02711371
Other study ID # ART_Can_01
Secondary ID
Status Completed
Phase N/A
First received March 4, 2016
Last updated February 1, 2017
Start date July 2015
Est. completion date December 2016

Study information

Verified date February 2017
Source University of Electronic Science and Technology of China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Cannabis dependence according to DSM 4 criteria

- 28 days of supervised abstinence

Exclusion Criteria:

- other DSM 4 diagnosis

- neurological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fMRI


Locations

Country Name City State
Germany University of Bonn / Department of Psychiatry Bonn NRW

Sponsors (3)

Lead Sponsor Collaborator
University of Electronic Science and Technology of China German Research Foundation, University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ratings of subjective experience (pleasantness, rewarding value) will be assessed after 28 days of abstinence Self-reported ratings of pleasantness & rewarding value during soft-pleasant touch. one timepoint = during fMRI assessment after 28 day abstinence period
Secondary Relapse interview assessed with Timeline-Followback Method Association between fMRI neural correlates and drug use during follow up period as predictor of relapse one timepoint = 24 months post-fMRI-session
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