Theta Burst TMS for Treatment of Methamphetamine Use Disorder
- Conditions
- Methamphetamine Abuse
- Interventions
- Device: Transcranial Magnetic StimulationDevice: Sham Transcranial Magnetic Stimulation
- Registration Number
- NCT06372288
- Lead Sponsor
- Carilion Clinic
- Brief Summary
This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm.
- Detailed Description
Patients who meet criteria for the study and who agree to participate in the research study will be randomized to an arm of the study by chance (like tossing a coin). The chance of receiving TMS or sham-TMS is equal. They will be enrolled in either the TMS or sham-TMS group (both groups involve 5 TMS or sham-TMS sessions). The study doctor and the participant will not know whether they are in the TMS or sham-TMS group. The purpose of this study is to determine if TMS is a potential treatment for methamphetamine use disorder. TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether a specific type of TMS (intermittent theta burst) over the forehead can produce a reduction in things that may prompt you to want to use methamphetamines.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Individuals actively struggling with Methamphetamine Use Disorder
- Must be currently enrolled in Carilion Clinic Office Based Addiction Treatment (OBAT) program
- Individuals currently struggling with alcohol use and/or benzodiazepine use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcranial Magnetic Stimulation (TMS) Transcranial Magnetic Stimulation This arm receives the TMS treatments. Sham-TMS Sham Transcranial Magnetic Stimulation This arm receives sham TMS treatments.
- Primary Outcome Measures
Name Time Method Stimulant Craving Questionnaire (STCQ) Baseline/Visit 2, daily during iTBS/Sham-TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS Self-rated cravings for stimulants
Urine Drug Screen (UDS) Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS Urine drug screens
- Secondary Outcome Measures
Name Time Method Clinical Global Impression - Improvement (CGI-I) Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS Clinician rated illness improvement
Clinical Global Impression - Severity (CGI-S) Screening/Visit 1 Clinician rated illness severity
Montgomery Asberg Depression Rating Scale (MADRS) Screening/Visit 1, Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS Clinician rated depression
Generalized Anxiety Disorder-7 (GAD-7) Screening/Visit1 and day 5 of iTBS/Sham TMS Self-rated anxiety severity
Patient Health Questionnaire-9 (PHQ-9) Screening/Visit 1 and day 5 of iTBS/Sham TMS self-rated depression severity
Hamilton Anxiety Scale (HAM-A) Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS Clinician rated anxiety
Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q) Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS Self-rated Quality of Life scale
Trial Locations
- Locations (1)
Carilion Clinic
🇺🇸Roanoke, Virginia, United States