The Longitudinal Study of Stimulant Use Disorder

NCT06073340 | Terminated

• 1 other identifier: STU-2023-0578
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stimulant Use; Stimulant-Related Disorder; Healthy

Outcome Measures

Primary Outcomes (1)

• Stimulant Use

  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 Outcomes (10)

• Demographic Differences in Stimulant Use

  5 years

• Longitudinal changes from baseline in self-reported stress assessed by Perceived Stress Scale

  5 years

• Longitudinal changes from baseline in symptom tracking assessed by the Concise Associated Symptom Tracking Scale (CAST-IRR)

  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)

  5 years

• Longitudinal changes from baseline in productivity assessed by Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)

  5 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Be an adult between the ages of 18-85, inclusive.
• Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions.
• 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).
• Be willing to provide consent and comply with all procedure instructions.
• Be willing to provide blood samples and participate in EEGs and MRIs.

You may not qualify if:

• 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.
• 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.
• Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75247, United States

Location

Related Publications (37)

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Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen collection occurs 4x/year and includes Urine Screening for Disease, Blood Sample for Laboratory Testing (CMP, CBC, hs-CRP, and disease serology), and Blood Sample for Storage. Venous blood samples for measurement of biomarkers will be collected from all participants. The whole blood collection tubes include anticoagulant tubes containing EDTA, ACD, lithium heparin, or sodium citrate, coagulant tubes, and specialty research tubes such as PAXGene tubes containing enzyme inhibition solutions. Serum, plasma, and cellular fractions will be isolated from whole blood. Urine and saliva samples are also collected for research purposes. Genetic information (including DNA and RNA) will be obtained from whole blood or isolated cells.

Study Officials

• Madhukar Trivedi, M.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 10, 2023
• Study Start: November 16, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)