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 |
- 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
- 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
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