Functional Connectivity Changes During Early Recovery as a Marker for Relapse

NCT ID: NCT02861820

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2021-01-26

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.

Conditions

Substance Use Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MRI: Brain Imaging Data Collection

Intervention Type: DEVICE

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.

MRI: Brain Imaging Data Collection

Intervention Type: DEVICE

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

Interventions

MRI: Brain Imaging Data Collection

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin O Lim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DA038984-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSYCH-2016-24183

Identifier Type: -

Identifier Source: org_study_id