The Longitudinal Study of Stimulant Use Disorder (STIM-RAD)

The University of Texas System (UT)

Status: Terminated

Conditions: Healthy; Stimulant-Related Disorder; Stimulant Use

Study type: Observational

Funder types: Other

Identifiers

NCT06073340

STU-2023-0578

Details and patient eligibility

About

This research is a 5-year observational, longitudinal registry study with no treatment or medication provided as part of participation. Individuals with current or lifetime stimulant use disorder, in addition to healthy control individuals, may be eligible to participate in this study. A variety of assessments and tasks including Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), blood draws, urine drug screens, and both self-report and clinician-rated assessments will be used to assess biomarkers in this population. This study has a visit schedule of four in-person visits and eight remote visits per year.

Full description

This project is a five-year observational study that will use a variety of assessments and tasks to phenotype participants with lifetime or current Stimulant Use Disorder as well as healthy control individuals. The data collection will include collecting urine samples for diagnostic tracking, socio-demographic and lifestyle factors, clinical and behavioral assessments, blood-based biomarkers, genomics, cell-based assays, EEG, and MRI to establish phenotypic biosignature subtypes over the longitudinal timeline.

Enrollment: 72 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be an adult between the ages of 18-85, inclusive.
2. Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions.
3. For participants with current/history of Stimulant Use Disorder: Subjects must meet MINI International Neuropsychiatric Inventory (MINI) criteria for current stimulant use disorder or meet MINI supplemental criterial for lifetime stimulant use disorder. For Healthy control individuals: Subjects must meet criteria for a healthy control: No history of substance use disorder or other mental illness as defined by the MINI International Neuropsychiatric Inventory (MINI).
4. Be willing to provide consent and comply with all procedure instructions.
5. Be willing to provide blood samples and participate in EEGs and MRIs.

Exclusion criteria

1. For participants with stimulus use disorder cohort: Have a history of schizophrenia, schizoaffective disorders, or chronic psychotic disorders based on the MINI. For healthy control individuals: Have a history of substance use disorder or any other psychiatric disorder as defined by the MINI and supplemental questions.
2. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
3. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.