ACTRN12622000762752Recruiting未知
Theta burst Transcranial Magnetic Stimulation (TMS) for Methamphetamine use disorder– A feasibility study to inform a multi-site Randomised Control Trial
Hunter New England Local Health District Drug and Alcohol Clinical Services0 sites30 target enrollmentStarted: May 27, 2022Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Aged 18-65 years
- •Meets DSM 5 criteria for moderate to severe MA use disorder
- •Current MA past month use
- •Able to give written informed consent
- •Be willing and able to comply with the requirements of the study
Exclusion Criteria
- •Other psychoactive substance use requiring withdrawal management pharmacotherapy in the 28 days preceding eligibility screening (e.g. alcohol withdrawal requiring diazepam)
- •Current pharmacotherapy for amphetamine use disorder (e.g. dexamphetamine) in the 28 days preceding eligibility screening.
- •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 DSM 5 criteria. Psychosis not otherwise specified (NOS), in remission, or drug-induced psychotic episodes are not exclusion criteria since these may be related to methamphetamine misuse.
- •Severe uncontrolled medical condition, diagnosis of neurological disorder or neurocognitive disorder. Prior neurosurgical procedure.
- •Contraindications to TMS (e.g. patients with epilepsy or seizure disorder, patients with implanted ferromagnetic equipment in their face or skull near the stimulation target, Cochlear implants, metal implant or electronic devices in the head, brain aneurysm clips/coils, VNS, pacemakers, deep brain stimulation, VP shunts, brain or neck stents, epilepsy, medical pump, hearing disorder, recent head injury).
- •Current or planned pregnancy
- •History of ECT treatment within the past three months.
- •History of any previous TMS treatment.
Investigators
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