Clinical trial NCT06424184: Accelerated rTMS for Substance Use Disorder and Depression
Official title: Substance Use Disorder Treatment With Accelerated Repetitive Transcranial Magnetic Stimulation for Depression (START-D)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stimulant Use
Depression
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Feasibility of an accelerated course of repetitive Transcranial Magnetic Stimulation (rTMS).
timeFrame: 3 weeks
Secondary outcomes:
measure: Attainment of response of rTMS intervention on stimulant use assessed by Urine Drug Screens.
timeFrame: 3 weeks
measure: Changes in stimulant craving during the 3-week treatment phase assessed by the Stimulant Craving Questionnaire (STCQ).
timeFrame: 3 weeks
measure: Changes in stimulant craving during the 3-week treatment phase assessed by a Visual Analog Drug Craving Scale (VAS).
timeFrame: 3 weeks
measure: Changes in stimulant craving during the 3-week treatment phase assessed by the Cue Craving Assessment.
timeFrame: 3 weeks
measure: Changes in frequency of self-reported stimulant use based on Timeline Followback (TLFB).
timeFrame: 6 weeks
measure: Changes in self-reported symptoms of suicidality during the 3-week treatment phase.
timeFrame: 3 weeks
measure: Changes in self-reported symptoms of depression during the 3-week treatment phase.
timeFrame: 3 weeks
measure: Changes in self-reported symptoms of irritability during the 3-week treatment phase.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Manish Jha, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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