TMS (Transcranial Magnetic Stimulation) for Methamphetamine Use Disorder in People Living With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Cue-induced methamphetamine craving
Study Overview
Brief Summary
The purpose of this study is to learn more about how accelerated theta burst stimulation affects methamphetamine craving and brain activity. Theta burst stimulation is a unique transcranial magnetic stimulation (TMS) paradigm that is efficient and potent.
Detailed Description
The investigators will compare how two theta burst paradigms, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), compare with sham TMS in changing methamphetamine craving and brain activity. iTBS, cTBS, and sham TMS will be delivered in an accelerated fashion (two sessions daily, separated by 50 minutes). iTBS will be delivered to the left dorsolateral prefrontal cortex (left dorsolateral prefrontal cortex), and cTBS will be delivered to the frontal pole. A brain MRI scan will be done before and after the iTBS/cTBS/sham TMS sessions. The study involves four visits. Each visit will last three hours. Hence, participants will spend a total of 12 hours in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults in the age group 18-65 years
- •Able to read and understand English
- •Able to provide informed consent
- •Diagnosed with HIV
- •History of current or previous Methamphetamine Use Disorder
- •Endorse craving for methamphetamine
- •Demonstrate an attentional bias for methamphetamine
Exclusion Criteria
- •Traumatic brain injury
- •h/o seizure disorder
- •h/o or current diagnosis of schizophrenia
- •intracranial metal shrapnel
- •previous adverse effects with TMS
- •sub-threshold consistency while performing behavioral tasks
- •lack of attentional bias to methamphetamine cues
- •a positive pregnancy test for female participants
- •abnormal brain MRI
Arms & Interventions
Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
Intervention: Sham TMS (Device)
Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
Intervention: intermittent theta burst stimulation (iTBS) (Device)
Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
Intervention: Sham TMS (Device)
Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
Intervention: intermittent theta burst stimulation (iTBS) (Device)
Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
Intervention: continuous theta burst stimulation (cTBS) (Device)
Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
Intervention: Sham TMS (Device)
Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
Intervention: intermittent theta burst stimulation (iTBS) (Device)
Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
Intervention: continuous theta burst stimulation (cTBS) (Device)
Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
Intervention: continuous theta burst stimulation (cTBS) (Device)
Outcomes
Primary Outcomes
Cue-induced methamphetamine craving
Time Frame: Baseline and before and after each TMS session up to 4 days
Measured on the visual analog scale (VAS) Scored 0 to 100 with 0=no craving and 100=the most craving.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gopalkumar Rakesh
Assistant Professor
University of Kentucky