Accelerated rTMS for Substance Use Disorder and Depression

Официальное название

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

Обзор

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 \[including methamphetamine or cocaine use disorder (MUD/CUD)\].

Подробное описание

This research is an open label feasibility trial of accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with stimulant use disorder. Participants will be recruited from an existing and ongoing longitudinal study of stimulant use disorder (STIM-RAD) (NCT06073340). Prior to initiating the accelerated course of rTMS, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete up to four (4) rTMS sessions of intermittent theta burst over left dorsolateral prefrontal cortex per day, up to five (5) days per week of the study, for a total of 50 sessions over a three (3) week period and will undergo electroencephalography (EEG), electrocardiography (ECG), urine drug screens, as well as self-report and clinician-rated assessments. A follow-up visit will be conducted 1 week after the last session of rTMS.

Вмешательства

• Устройство Accelerated Repetitive Transcranial Magnetic Stimulation
  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.

Первичные конечные точки

• Feasibility of an accelerated course of repetitive Transcranial Magnetic Stimulation (rTMS). [Срок оценки: 3 weeks]

Вторичные конечные точки (8)

• Attainment of response of rTMS intervention on stimulant use assessed by Urine Drug Screens. [Срок оценки: 3 weeks]
• Changes in stimulant craving during the 3-week treatment phase assessed by the Stimulant Craving Questionnaire (STCQ). [Срок оценки: 3 weeks]
• Changes in stimulant craving during the 3-week treatment phase assessed by a Visual Analog Drug Craving Scale (VAS). [Срок оценки: 3 weeks]
• Changes in stimulant craving during the 3-week treatment phase assessed by the Cue Craving Assessment. [Срок оценки: 3 weeks]
• Changes in frequency of self-reported stimulant use based on Timeline Followback (TLFB). [Срок оценки: 6 weeks]
• Changes in self-reported symptoms of suicidality during the 3-week treatment phase. [Срок оценки: 3 weeks]
• Changes in self-reported symptoms of depression during the 3-week treatment phase. [Срок оценки: 3 weeks]
• Changes in self-reported symptoms of irritability during the 3-week treatment phase. [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UT Southwestern Medical Center — Dallas

Публикации

• 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
• 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
• 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
• 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
• 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
• 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) PMID 12946886
• 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 200 PMID 16199008
• 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

Идентификаторы

NCT: NCT06424184 · STU-2024-0232

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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