Accelerated rTMS for Substance Use Disorder and Depression

NCT06424184 | Recruiting FDA Device

• 1 other identifier: STU-2024-0232
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of an accelerated course of repetitive Transcranial Magnetic Stimulation (rTMS).

  Feasibility will be measured by completion of at least 30 out of 50 sessions of rTMS.

  3 weeks

Secondary Outcomes (8)

• Attainment of response of rTMS intervention on stimulant use assessed by Urine Drug Screens.

  3 weeks

• Changes in stimulant craving during the 3-week treatment phase assessed by the Stimulant Craving Questionnaire (STCQ).

  3 weeks

• Changes in stimulant craving during the 3-week treatment phase assessed by a Visual Analog Drug Craving Scale (VAS).

  3 weeks

• Changes in stimulant craving during the 3-week treatment phase assessed by the Cue Craving Assessment.

  3 weeks

• Changes in frequency of self-reported stimulant use based on Timeline Followback (TLFB).

  6 weeks

Study Arms (1)

rTMS Intervention

EXPERIMENTAL

Eligible participants who are enrolled will receive an accelerated course of repetitive Transcranial Magnetic Stimulation.

Device: Accelerated Repetitive Transcranial Magnetic Stimulation

Interventions

Accelerated Repetitive Transcranial Magnetic Stimulation DEVICE

The rTMS protocol implemented in this study will include approximately 10-minute long sessions of intermittent theta burst stimulation (iTBS) with at least 50 minutes in between iTBS sessions. Study participants will receive the rTMS intervention for up to 50 sessions across a three-week period. The total of 50 sessions will be administered as up to 4 sessions each day, up to 5 days per week over an up to 3-week-long period.

rTMS Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged 18-65 years, inclusive.
• 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.
• Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
• 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).
• Have a PHQ9 of greater than or equal to five (5).
• Be willing to provide urine samples, EEGs, and ECGs.
• Be willing to use appropriate birth control method during the treatment phase of the study, if individual is of childbearing potential.

You may not qualify if:

• 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.
• 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).
• Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
• Have a documented history of brain lesion(s) and/or tumor(s).
• Have metal implants or non-removable metal objects above the neck.
• Current pregnancy as determined by a urine screening.
• Current or lifetime manic or hypomanic episode, defined by MINI diagnostic interview.
• Current psychotic disorder.
• Are a prisoner or in police custody at the time of eligibility screening.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75247, United States

RECRUITING

Related Publications (9)

• Northrup TF, Green C, Walker R, Greer TL, Trivedi MH. On the invariance of the Stimulant Craving Questionnaire (STCQ) across cocaine and methamphetamine users. Addict Behav. 2015 Mar;42:144-7. doi: 10.1016/j.addbeh.2014.11.020. Epub 2014 Nov 25.

  PMID: 25462663 BACKGROUND

• Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.

  PMID: 2197679 BACKGROUND

• Sobell LC, Sobell MB, Leo GI, Cancilla A. Reliability of a timeline method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addict. 1988 Apr;83(4):393-402. doi: 10.1111/j.1360-0443.1988.tb00485.x. No abstract available.

  PMID: 3395719 BACKGROUND

• Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.

  PMID: 21733476 BACKGROUND

• Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.

  PMID: 17606655 BACKGROUND

• Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

  PMID: 12946886 BACKGROUND

• Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.

  PMID: 16199008 BACKGROUND

• Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.

  PMID: 21733477 BACKGROUND

• Jha MK, Minhajuddin A, South C, Rush AJ, Trivedi MH. Irritability and Its Clinical Utility in Major Depressive Disorder: Prediction of Individual-Level Acute-Phase Outcomes Using Early Changes in Irritability and Depression Severity. Am J Psychiatry. 2019 May 1;176(5):358-366. doi: 10.1176/appi.ajp.2018.18030355. Epub 2019 Mar 29.

  PMID: 30922100 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Manish Jha, M.B.B.S

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor Helmbrecht, B.S.A.

CONTACT

(214) 998-6504; Taylor.Helmbrecht@UTSouthwestern.edu

Teresa Slettebo, B.A.

CONTACT

(214) 998-5649; Teresa.Slettebo@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label trial

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 22, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)