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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Transcranial Magnetic Stimulation (TMS using Intermittent theta burst stimulation (iTBS)
Participants will not receive intermittent theta burst stimulation during the sham-TMS sessions
Carilion Clinic
Roanoke, Virginia, United States
RECRUITINGStimulant Craving Questionnaire (STCQ)
Self-rated cravings for stimulants
Time frame: 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
Urine Drug Screen (UDS)
Urine drug screens
Time frame: 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
Generalized Anxiety Disorder-7 (GAD-7)
Self-rated anxiety severity
Time frame: Screening/Visit1 and day 5 of iTBS/Sham TMS
Patient Health Questionnaire-9 (PHQ-9)
self-rated depression severity
Time frame: Screening/Visit 1 and day 5 of iTBS/Sham TMS
Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q)
Self-rated Quality of Life scale
Time frame: 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
Hamilton Anxiety Scale (HAM-A)
Clinician rated anxiety
Time frame: 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
Montgomery Asberg Depression Rating Scale (MADRS)
Clinician rated depression
Time frame: 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
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Clinical Global Impression - Severity (CGI-S)
Clinician rated illness severity
Time frame: Screening/Visit 1
Clinical Global Impression - Improvement (CGI-I)
Clinician rated illness improvement
Time frame: 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