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

December 11, 2023 updated by: Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Observational Longitudinal Study of Individuals With Stimulant Use Disorder: Research and Development of a Biosignature

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulant Use
Time Frame: 5 years
The primary outcome measure is maintaining a naturalistic database of stimulant use disorders using urine drug screens and self-reported use through the Timeline follow-back questionnaires.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Differences in Stimulant Use
Time Frame: 5 years
Based on racial, ethnic, and socioeconomic status, compare the demographic disparity of the stimulant use disorder compared to healthy controls.
5 years
Longitudinal changes from baseline in self-reported stress assessed by Perceived Stress Scale
Time Frame: 5 years
Participants' perceived level of stress will be assessed with the Perceived Stress Scale (PSS), a 10-item self-administered scale that is used to measure an individual's level of perceived stress in the past month. The PSS score is obtained by summing across items (responses to the four positively stated items first need to be reversed). Individual scores on the PSS can range from 0 to 40 where higher scores indicate higher levels of perceived stress.
5 years
Longitudinal changes from baseline in symptom tracking assessed by the Concise Associated Symptom Tracking Scale (CAST-IRR)
Time Frame: 5 years
Participants' associated mood symptoms will be assessed using a 10-item version of the Concise Associated Symptom Tracking Scale Self-Report (CAST-IRR), a self-report scale that assesses irritability. Each individual item is rated on a 5-point Likert scale with responses of "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree" corresponding to scores of 1, 2, 3, 4, and 5, respectively, and a total score of 5-50. An increased score indicates higher irritability levels.
5 years
Longitudinal changes from baseline in quality of life assessed by the Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Time Frame: 5 years
The Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a 16-item self-administered questionnaire that captures degree of enjoyment and satisfaction experienced by an individual over the past week. Each question is rated on a 5-point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as a percentage maximum possible score.
5 years
Longitudinal changes from baseline in productivity assessed by Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)
Time Frame: 5 years
The Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP) Version 2.0 will be used to assess work impairment due to substance use disorder. Six items comprise the measure, with the first item asking about whether participants are currently employed/working for pay. If so, participants complete five additional items, which include how many hours from work are missed due to substance use disorder (SUD), productivity while working and ability to do regular daily activities besides work. The latter two items are scored on a scale of 0 (SUD had no effect on work) to 10 (SUD completely prevented me from working).
5 years
Longitudinal changes from baseline in symptoms of mania assessed by the Altman Self-Rating Mania scale (ASRM).
Time Frame: 5 years
The Altman Self-Rating Mania Scale (ASRM) is a 5-item self-administered scale designed to assess the presence and/or severity of manic symptoms. Each item on the measure is rated on a 5-point scale (i.e., 1 to 5) with response categories having different anchors depending on the item. The ASRM score ranges from 5-25 with higher scores indicating greater severity of manic symptoms. A cutoff score of 6 or higher indicates a high probability of a manic or hypomanic condition. A score of 5 or lower is less likely to be associated with significant symptoms of mania.
5 years
Longitudinal changes from baseline sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 5 years
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The 19-items are grouped into seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each of these seven subcategories is weighted equally on a 0-3 scale, which are then combined to yield a global PSQI score with a range of 0-21. A higher PSQI score indicates more acute sleep disturbances.
5 years
Longitudinal changes from baseline on proteomic, metabolomic, transcriptomic, and epigenomic factors assessed using fluid-based biomarkers
Time Frame: 5 years
Comparison of Longitudinal changes in fluid-based biomarkers as measured by proteomic methods, metabolomics methods, transcriptomic methods, genomic methods, and epigenomic methods in patients with Stimulant Use Disorder versus Healthy Controls.
5 years
Longitudinal changes from baseline Electroencephalogram (EEG) metrics
Time Frame: Baseline and every three months for five years

The EEG includes pre-treatment alpha and theta EEG power and source localization measures of theta activity in the rostral Anterior Cingulate Cortex, the Loudness Dependency of Auditory Evoked Potentials, and assessment of psychomotor slowing (measured during reaction time, word fluency, implicit emotion processing or regulation, and reward learning tasks), cognitive control (as measured by interference and post-error adjustments), working memory, and reward-conditioned learning.

The EEG metrics will be measured in terms of Alpha (8-13 Hz), beta (13-30 Hz), delta (0.5-4 Hz), and theta (4-7 Hz) waves and compared with baseline every 3 months for 5 years.
Baseline and every three months for five years
Longitudinal changes from baseline Magnetic Resonance Imaging (MRI) metrics
Time Frame: Baseline and every six months for five years

The Structural MRI measures cortical thickness. Structural MRI volume differences of the brain region will be measured and compared to the baseline every 6 months.

The Functional MRI measures resting state intracerebral connectivity. Changes in functional connectivity will be assessed from baseline to every 6 months for 5-years during enrollment period.

Pulsed Arterial Spin Labeling (PASL), a measure of regional cerebral blood flow, will be assessed through changes in the cerebral metabolic oxygen rate measure from baseline to every 6 months for 5-years during enrollment period.

Diffusion Tensor Imaging (DTI) will assess changes in the white matter connectivity measure from baseline to every 6 months for 5 years during enrollment period.

Magnetic Resonance Spectroscopy (MRS) will assess changes in the neurochemistry of glutamate and GABA from baseline to every 6 months for 5 years during enrollment period.
Baseline and every six months for five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Madhukar Trivedi, M.D., Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Estimated)

November 16, 2033

Study Completion (Estimated)

November 16, 2033

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STU-2023-0578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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