Functional Connectivity Changes During Early Recovery as a Marker for Relapse

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT02861820

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

160

Enrollment

Location

66.9

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorder	Device: MRI: Brain Imaging Data Collection

Study Design

Study Type:

Observational

Actual Enrollment :

160 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Functional Connectivity Changes During Early Recovery as a Marker for Relapse

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Mar 4, 2020

Actual Study Completion Date :

Jan 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Substance Use Disorder (SUD) Participants in the SUD group will: Complete a diagnostic screening interview at baseline. Complete questionnaires and computer tasks at baseline, 1 month and 2 month time points. Complete MRI brain imaging data collection at the baseline, 1 month and 2 month time points. Complete 9 follow-up phone calls to assess for relapse.	Device: MRI: Brain Imaging Data Collection 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: Complete a diagnostic screening interview at baseline. Complete questionnaires and computer tasks at baseline and 2 month time points. Complete MRI brain imaging data collection at the baseline and 2 month time points.	Device: MRI: Brain Imaging Data Collection This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.

Arm

Intervention/Treatment

Substance Use Disorder (SUD)

Participants in the SUD group will: Complete a diagnostic screening interview at baseline. Complete questionnaires and computer tasks at baseline, 1 month and 2 month time points. Complete MRI brain imaging data collection at the baseline, 1 month and 2 month time points. Complete 9 follow-up phone calls to assess for relapse.

Device: MRI: Brain Imaging Data Collection

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: Complete a diagnostic screening interview at baseline. Complete questionnaires and computer tasks at baseline and 2 month time points. Complete MRI brain imaging data collection at the baseline and 2 month time points.

Device: MRI: Brain Imaging Data Collection

This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.

Outcome Measures

Primary Outcome Measures

Brain connectivity [Change from Baseline, to 2 months]
3T MRI scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.