Accelerated rTMS for Substance Use Disorder and Depression

Description

This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with depression and stimulant use disorder \[including methamphetamine or cocaine use disorder (MUD/CUD)\].

Conditions

Stimulant Use, Depression

Study Overview

Study Details

Study overview

This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with depression and stimulant use disorder \[including methamphetamine or cocaine use disorder (MUD/CUD)\].

Substance Use Disorder Treatment With Accelerated Repetitive Transcranial Magnetic Stimulation for Depression (START-D)

Accelerated rTMS for Substance Use Disorder and Depression

Condition
Stimulant Use
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75247

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Be aged 18-65 years, inclusive.
  • 2. Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions, and be willing to comply with all study procedure instructions.
  • 3. Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
  • 4. Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) or other Stimulant Use Disorder over the past 12 months (as determined by the MINI International Neuropsychiatric Interview).
  • 5. Have a PHQ9 of greater than or equal to five (5).
  • 6. Be willing to provide urine samples, EEGs, and ECGs.
  • 7. Be willing to use appropriate birth control method during the treatment phase of the study, if individual is of childbearing potential.
  • 1. Have a current pattern of alcohol, benzodiazepine, or other sedative/hypnotic use that would preclude safe participation in the study, as determined by the PI or their designee.
  • 2. Have a history of a serious medical disorder that, in the opinion of the PI or their designee, would make it unsafe to participate in the study or may prevent collection of study data (e.g., disabling terminal diagnosis for which hospice care is being sought; serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy and/or is clinically stable on therapy, in the opinion of the PI or their designee, prior to study entry).
  • 3. Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
  • 4. Have a documented history of brain lesion(s) and/or tumor(s).
  • 5. Have metal implants or non-removable metal objects above the neck.
  • 6. Current pregnancy as determined by a urine screening.
  • 7. Current or lifetime manic or hypomanic episode, defined by MINI diagnostic interview.
  • 8. Current psychotic disorder.
  • 9. Are a prisoner or in police custody at the time of eligibility screening.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Manish Jha, M.B.B.S, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2027-06