Clinical trial NCT06073340: The Longitudinal Study of Stimulant Use Disorder
Official title: Observational Longitudinal Study of Individuals With Stimulant Use Disorder: Research and Development of a Biosignature
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stimulant Use
Stimulant-Related Disorder
Healthy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1,000 adults who meet eligibility criteria for Stimulant Use Disorder, as confirmed by the MINI and supplement. Additionally, 500 healthy control individuals will be enrolled. Current stimulant use disorder will be supported by a urine sample positive for stimulants (such as amphetamines, methamphetamine, cocaine, 3,4-Methylenedioxymethamphetamine, or prescription stimulants).

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stimulant Use
timeFrame: 5 years
Secondary outcomes:
measure: Demographic Differences in Stimulant Use
timeFrame: 5 years
measure: Longitudinal changes from baseline in self-reported stress assessed by Perceived Stress Scale
timeFrame: 5 years
measure: Longitudinal changes from baseline in symptom tracking assessed by the Concise Associated Symptom Tracking Scale (CAST-IRR)
timeFrame: 5 years
measure: Longitudinal changes from baseline in quality of life assessed by the Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
timeFrame: 5 years
measure: Longitudinal changes from baseline in productivity assessed by Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)
timeFrame: 5 years
measure: Longitudinal changes from baseline in symptoms of mania assessed by the Altman Self-Rating Mania scale (ASRM).
timeFrame: 5 years
measure: Longitudinal changes from baseline sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 5 years
measure: Longitudinal changes from baseline on proteomic, metabolomic, transcriptomic, and epigenomic factors assessed using fluid-based biomarkers
timeFrame: 5 years
measure: Longitudinal changes from baseline Electroencephalogram (EEG) metrics
timeFrame: Baseline and every three months for five years
measure: Longitudinal changes from baseline Magnetic Resonance Imaging (MRI) metrics
timeFrame: Baseline and every six months for five years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Professor
name: Madhukar Trivedi, M.D.
role: PRINCIPAL_INVESTIGATOR
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