Functional Connectivity Changes During Early Recovery as a Marker for Relapse

Substance Use Disorder Clinical Trial

Official title:

Functional Connectivity Changes During Early Recovery as a Marker for Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861820
• Other study ID #: PSYCH-2016-24183
• Secondary ID: 1R01DA038984-01A
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: January 26, 2021

Study information

• Verified date: January 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 26, 2021
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Device:
• MRI: Brain Imaging Data Collection
This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain connectivity	3T MRI scan	Change from Baseline, to 2 months