Theta Burst Transcranial Magnetic Stimulation for the Treatment of Methamphetamine Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Methamphetamine Abuse
- Sponsor
- Carilion Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Stimulant Craving Questionnaire (STCQ)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sooraj John
Physician
Carilion Clinic
Eligibility Criteria
Inclusion Criteria
- •Individuals actively struggling with Methamphetamine Use Disorder
- •Must be currently enrolled in Carilion Clinic Office Based Addiction Treatment (OBAT) program
Exclusion Criteria
- •Individuals currently struggling with alcohol use and/or benzodiazepine use
Outcomes
Primary Outcomes
Stimulant Craving Questionnaire (STCQ)
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
Self-rated cravings for stimulants
Urine Drug Screen (UDS)
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
Urine drug screens
Secondary Outcomes
- 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)
- Clinical Global Impression - Severity (CGI-S)(Screening/Visit 1)
- 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)
- Generalized Anxiety Disorder-7 (GAD-7)(Screening/Visit1 and day 5 of iTBS/Sham TMS)
- Patient Health Questionnaire-9 (PHQ-9)(Screening/Visit 1 and day 5 of iTBS/Sham TMS)
- 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)
- 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)