Methamphetamine Abuse
Conditions
Keywords
Transcranial Magnetic Stimulation (TMS), methamphetamine use disorder
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.
Interventions
DEVICETranscranial Magnetic Stimulation
Transcranial Magnetic Stimulation (TMS using Intermittent theta burst stimulation (iTBS)
DEVICESham Transcranial Magnetic Stimulation
Participants will not receive intermittent theta burst stimulation during the sham-TMS sessions
Sponsors
Virginia Polytechnic Institute and State University
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions.
Intervention model description
Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Generalized Anxiety Disorder-7 (GAD-7) | Screening/Visit1 and day 5 of iTBS/Sham TMS | Self-rated anxiety severity |
| Clinical Global Impression - Severity (CGI-S) | Screening/Visit 1 | Clinician rated illness severity |
| 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 |
| 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 |
| Patient Health Questionnaire-9 (PHQ-9) | Screening/Visit 1 and day 5 of iTBS/Sham TMS | self-rated depression severity |
Countries
United States
Contacts
Primary ContactSooraj John, M.D.
Backup ContactMaryann Hollen, B.S.
Outcome results
None listed