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Functional Connectivity Changes During Early Recovery as a Marker for Relapse

Functional Connectivity Changes During Early Recovery as a Marker for Relapse

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02861820
Enrollment
160
Registered
2016-08-10
Start date
2015-07-01
Completion date
2021-01-26
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorder

Keywords

fMRI, brain networks, biomarker, relapse, stimulants

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.

Interventions

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Brain connectivityChange from Baseline, to 2 months3T MRI scan

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026