- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02801422
Neural Indices Associated With Relapse in Cannabis Dependence
October 26, 2018 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Altered Neural Activation Patterns of Emotional Processing in Dependent Cannabis Users Associated With Relapse
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
75
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
-
-
North Rhine Westfalia
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Bonn, North Rhine Westfalia, Germany, 53127
- Recruiting
- University of Bonn
-
Contact:
- Benjamin Becker, PhD
- Phone Number: +4917620090499
- Email: ben_becker@gmx.de
-
Contact:
- Kaeli Zimmermann, MSc
- Phone Number: +4922828719704
- Email: kaeli.zimmermann@gmx.de
-
-
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
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cannabis dependent individuals
Description
Inclusion Criteria:
- Cannabis Dependence
- 24 hours abstinence
Exclusion Criteria:
- other DSM-4 diagnosis
- neurological disorder
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy control subjects
socio-demographically matched
|
|
|
Cannabis Dependence
ages 18-40
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fMRI neural activation patterns of emotional processing
Time Frame: one time point = fMRI assessment after minimum 24 hours of abstinence
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timeline Followback Interviews
Time Frame: one time point = 12 months after fMRI data acquisition
|
Association between fMRI correlates and drug use during follow up preiod as predictor for relapse
|
one time point = 12 months after fMRI data acquisition
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
February 1, 2016
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
June 11, 2016
First Submitted That Met QC Criteria
June 11, 2016
First Posted (Estimate)
June 15, 2016
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 26, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ART_Can_03
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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