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Neural Indices Associated With Relapse in Cannabis Dependence

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ClinicalTrials.gov Identifier: NCT02801422
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
German Research Foundation
University Hospital, Bonn
Information provided by (Responsible Party):
Benjamin Becker, University of Electronic Science and Technology of China

Tracking Information
First Submitted Date June 11, 2016
First Posted Date June 15, 2016
Last Update Posted Date October 29, 2018
Study Start Date February 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neural Indices Associated With Relapse in Cannabis Dependence
Official Title Altered Neural Activation Patterns of Emotional Processing in Dependent Cannabis Users Associated With Relapse
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cannabis dependent individuals
Condition Cannabis Dependence
Intervention Other: fMRI
Study Groups/Cohorts
  • Cannabis Dependence
    ages 18-40
    Intervention: Other: fMRI
  • Healthy control subjects
    socio-demographically matched
    Intervention: Other: fMRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2016)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Cannabis Dependence
  • 24 hours abstinence

Exclusion Criteria:

  • other DSM-4 diagnosis
  • neurological disorder
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Benjamin Becker, PhD +8618584070309 ben_becker@gmx.de
Contact: Kaeli Zimmermann, MSc +49022828719704 kaeli.zimmermann@gmx.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02801422
Other Study ID Numbers ART_Can_03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Benjamin Becker, University of Electronic Science and Technology of China
Study Sponsor University of Electronic Science and Technology of China
Collaborators
  • German Research Foundation
  • University Hospital, Bonn
Investigators Not Provided
PRS Account University of Electronic Science and Technology of China
Verification Date October 2018