- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02711371
Social and Emotional Brain Function in Cannabis Users
February 1, 2017 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Long-term Effects of Cannabis Use on Social and Emotional Brain Processes in Dependent Cannabis Users After a 28 Day Abstinence Period
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
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Bonn, NRW, Germany, 53111
- University of Bonn / Department of Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cannabis dependent individuals
Description
Inclusion Criteria:
- Cannabis dependence according to DSM 4 criteria
- 28 days of supervised abstinence
Exclusion Criteria:
- other DSM 4 diagnosis
- neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cannabis Dependence
Cannabis dependent individuals according to DSM 4 criteria, aged 18-40 years
|
|
|
Healthy
Healthy controls, socio-demographically matched
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fMRI neural activation patterns of social-emotional brain processes after 28 day abstinence
Time Frame: one timepoint = fMRI assessment after 28 day abstinence period
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Self-reported ratings of pleasantness & rewarding value during soft-pleasant touch.
|
one timepoint = during fMRI assessment after 28 day abstinence period
|
|
Relapse interview assessed with Timeline-Followback Method
Time Frame: one timepoint = 24 months post-fMRI-session
|
Association between fMRI neural correlates and drug use during follow up period as predictor of relapse
|
one timepoint = 24 months post-fMRI-session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
March 4, 2016
First Submitted That Met QC Criteria
March 13, 2016
First Posted (Estimate)
March 17, 2016
Study Record Updates
Last Update Posted (Estimate)
February 2, 2017
Last Update Submitted That Met QC Criteria
February 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ART_Can_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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