- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02861820
Functional Connectivity Changes During Early Recovery as a Marker for Relapse
January 19, 2022 updated by: University of Minnesota
The study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines.
More specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery.
This study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought).
Results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
160
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
-
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Minnesota
-
Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult individuals with Substance Use Disorder
Description
Inclusion Criteria:
- At least 18 but no more than 45 years old at the time of consent.
- Able to provide written consent and comply with study procedures.
Exclusion Criteria:
- Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, HIV).
- Any contraindications to MRI scanning (i.e. metal implants, pacemakers, etc.).
- Intellectual developmental disorder as defined in the DSM-V. Participant may have a diagnosis of an Axis I disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable.
- Actively suicidal.
- Positive screen for alcohol and/or drugs. Participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again.
- Evidence for Wernicke-Korsakoff syndrome.
- Healthy Controls may never have had any form of substance use disorder other than caffeine or nicotine. Nicotine use will be recorded but will not be an exclusion criterion.
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: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Substance Use Disorder (SUD)
Participants in the SUD group will:
|
This study has no intervention, it is observational.
The investigator will collect brain imaging data and behavioral assessments.
|
Healthy Control (HC)
Participants in the HC group will:
|
This study has no intervention, it is observational.
The investigator will collect brain imaging data and behavioral assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain connectivity
Time Frame: Change from Baseline, to 2 months
|
3T MRI scan
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Change from Baseline, to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kelvin O Lim, MD, University of Minnesota
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 (Actual)
July 1, 2015
Primary Completion (Actual)
March 4, 2020
Study Completion (Actual)
January 26, 2021
Study Registration Dates
First Submitted
August 1, 2016
First Submitted That Met QC Criteria
August 5, 2016
First Posted (Estimate)
August 10, 2016
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCH-2016-24183
- 1R01DA038984-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
As requested
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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