Accelerated rTMS for Substance Use Disorder and Depression

University of Texas Southwestern Medical Center40 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stimulant Use Depression

Interventions

Accelerated Repetitive Transcranial Magnetic StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 weeks

Secondary Outcomes

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

Attainment of response is defined as 3 out of 5 negative urine samples for stimulants (cocaine, amphetamines), in week 3 of treatment.

Time frame: 3 weeks

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

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."

Time frame: 3 weeks

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

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).

Time frame: 3 weeks

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

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.

Central 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

Data from ClinicalTrials.gov

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