Accelerated rTMS for Substance Use Disorder and Depression
- Conditions
- Stimulant UseDepression
- Interventions
- Device: Accelerated Repetitive Transcranial Magnetic Stimulation
- Registration Number
- NCT06424184
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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 \[including methamphetamine or cocaine use disorder (MUD/CUD)\].
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rTMS Intervention Accelerated Repetitive Transcranial Magnetic Stimulation Eligible participants who are enrolled will receive an accelerated course of repetitive Transcranial Magnetic Stimulation.
- Primary Outcome Measures
Name Time Method Feasibility of an accelerated course of repetitive Transcranial Magnetic Stimulation (rTMS). 3 weeks Feasibility will be measured by completion of at least 30 out of 50 sessions of rTMS.
- Secondary Outcome Measures
Name Time Method Attainment of response of rTMS intervention on stimulant use assessed by Urine Drug Screens. 3 weeks Attainment of response is defined as 3 out of 5 negative urine samples for stimulants (cocaine, amphetamines), in week 3 of treatment.
Changes in stimulant craving during the 3-week treatment phase assessed by a Visual Analog Drug Craving Scale (VAS). 3 weeks Craving for stimulants and other substances will be self-reported by participants on a Visual Analog Drug Craving Scale (VAS) which ranges from 0 (no craving) to 100 (most intense craving possible).
Changes in stimulant craving during the 3-week treatment phase assessed by the Stimulant Craving Questionnaire (STCQ). 3 weeks The Stimulant Craving Questionnaire (STCQ) is a 10-item self-report measure derived from the 10-item Cocaine Craving Questionnaire-Brief and the original 46-item Cocaine Craving Questionnaire-Now. The STCQ assesses current craving for stimulants (cocaine, methamphetamine, and other stimulants) using a seven-point scale, with answers ranging from "strongly disagree" to "agree."
Changes in stimulant craving during the 3-week treatment phase assessed by the Cue Craving Assessment. 3 weeks Current craving for stimulants will be assessed using the Cue Craving Assessment. Participants will be asked about their current craving for and ability to resist stimulants on a 0-10 scale immediately after cue exposure prior to rTMS and after the completion of each rTMS session. A "0" rating indicates the absence of craving or the absence of the ability to resist use, whereas a "10" rating indicates the highest craving or strongest ability to resist use.
Changes in frequency of self-reported stimulant use based on Timeline Followback (TLFB). 6 weeks The Timeline Followback (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances, including but not limited to stimulants, and polysubstance use starting at the Screening Visit and continuing throughout study participation. During the Screening Visit, this form will be used to assess illicit use of substances for the 30-day period prior to written consent. During the study, TLFB will be administered to document the participant's self-reported use of illicit substances, nicotine, and tobacco for each visit since the previous TLFB assessment. Participant's drug of choice will be asked and determined by study coordinator and recorded along with the TLFB assessment.
Changes in self-reported symptoms of suicidality during the 3-week treatment phase. 3 weeks The Concise Health Risk Tracking - Self-Report (CHRT-SR) is a 14-item self-report assessment of suicidality and related thoughts and behaviors. The scale is designed to track suicidality quickly and easily in a manner consistent with the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Participants are asked to rate the extent that they have related to fourteen different statements on a scale of "strongly disagree" to "strongly agree." A higher score indicates higher suicidality.
Changes in self-reported symptoms of depression during the 3-week treatment phase. 3 weeks The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) will assess overall depressive symptoms. The total score of QIDS-SR (range of 0-27) is based on the nine Diagnostic and Statistical Manual of Mental Disorders (DSM-lV) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease, and psychomotor agitation/retardation. Each question is scored on a 0-3 scale based on the participant's response. A higher score indicates higher depressive symptoms.
Changes in self-reported symptoms of irritability during the 3-week treatment phase. 3 weeks A 10-item version of the Concise Associated Symptom Tracking Scale Self-Report (CAST-IRR) will be used to assess associated mood symptoms. Participants are asked to rate the extent that they have related to ten different statements in the past week on a 5-point Likert scale (from 1, "strongly disagree," to 5, "strongly agree," where a higher score indicates increased symptoms). Some items in the CAST-IRR include: "I wish people would just leave me alone"; "I feel very uptight"; "I find myself saying or doing things without thinking"; "Lately everything seems to be annoying me"; and "I find people get on my nerves easily."
Trial Locations
- Locations (1)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States