Status:
COMPLETED
Pilot TMS for Methamphetamine Use Disorder
Lead Sponsor:
Ryan M. Carnahan
Collaborating Sponsors:
University of New Mexico
University of Utah
Conditions:
Stimulant Dependence
Methamphetamine-dependence
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This is a pilot study to test the feasibility of a recruitment strategy and study protocol to examine the effects of a dual target transcranial magnetic stimulation treatment in methamphetamine use di...
Detailed Description
Overview: This is a single-arm clinical trial, with historical controls as a comparison group for select outcomes. Subjects with MAUD will receive 16 sessions of dual-target theta burst stimulation to...
Eligibility Criteria
Inclusion
- Diagnosed with an active methamphetamine use disorder
- Is engaged in psychosocial treatment or articulates a plan to engage in psychosocial treatment for methamphetamine use disorder during the study period
- Age 18 to 60 years
- Able to consent for treatment and research participation
- English-speaking
- Receiving care from UIHC's Addiction Medicine service. This includes patients in the Crisis Stabilization Unit, seen by the inpatient consultation service, enrolling in partial hospitalization or intensive outpatient treatment, or seen in the outpatient Addiction Medicine clinics.
Exclusion
- Age less than 18 years
- Patients that are excluded during TMS assessment including: patients with epilepsy or seizure disorder, patients with implanted ferromagnetic equipment in their face or skull near the stimulation target.
- Current medical treatment with clozapine or stimulants.
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, that is deemed by research team psychiatrists not to have been drug-induced. Psychotic disorder not associated with drug use per the MINI International Neuropsychiatric Interview. Psychosis NOS, in remission, or drug-induced psychotic episodes are not exclusion criteria since these may be related to methamphetamine misuse.
- Lacks the mental capacity to provide informed consent (i.e. not able to demonstrate understanding of the risks and benefits of participation)
- Has a court appointed guardian.
- Unstable medical illness.
- Current diagnosis of neurological disorder or neurocognitive disorder.
- Prior neurosurgical procedure.
- History of seizure.
- History of ECT treatment within the past three months.
- History of any previous TMS treatment.
- Known inability to complete the protocol, as assessed by asking them if they are able to make it to all visits for this study without assistance.
- MRI Exclusion criteria:
- Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
- Metal in body including bullets, shrapnel, metal slivers
- Claustrophobia
- Uncontrolled high blood pressure
- Atrial fibrillation
- Significant heart disease
- Hemodynamic instability
- Kidney disease
- Pregnant
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04449055
Start Date
October 6 2020
End Date
March 31 2022
Last Update
February 21 2023
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242