Sakai #23-1044 TMS Study

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Description

The study will involve a baseline assessment, spending 1 week in the hospital (receiving 40 transcranial magnetic stimulation treatments over 5 days) and 12 weeks of follow up. Participants will have weekly visits with the research staff to report on substance use and other symptoms and monthly visits with the study psychiatrist. Half of the participants will receive real transcranial magnetic stimulation (TMS) and half will receive sham stimulation. Individuals who enroll in the study will also receive access to a free online cognitive behavioral therapy program called CBT4CBT which has previously been validated as a substance use disorder treatment in prior studies. If you want to learn more about our lab, please visit our website: https://medschool.cuanschutz.edu/psychiatry/research/faculty-labs/cona-lab To fill out a confidential pre-screening survey to see if you may be eligible use this link: https://redcap.link/tms_study

Details
Age
Adult
Eligibility
(1) Age 21-65 years inclusive; (2) Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder; (3) At least 10 days of methamphetamine use out of the last month; (4) Provides a urine drug screen positive for methamphetamine; (5) Able to provide informed consent; (6) No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry.Inclusion Criteria: (1) Age 21-65 years inclusive; (2) Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder; (3) By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month; (4) Provides a urine drug screen positive for methamphetamine; (5) Able to provide informed consent; (6) No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry. Exclusion Criteria: (1) Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5; (2) Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder; (3) Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year; (4) Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe; (5) Presence of a clinically significant abnormality on baseline MRI; (6) Inability to have an MRI; (7) Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study); (8) Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study); (9) History of head injury with loss of consciousness for more than 15 minutes; (10) Diagnosis of dementia; (11) Prescribed benzodiazepines or anticonvulsants; (12) Currently enrolled in formal substance use disorder treatment; (13) Metal implants or non-removable metal objects above the waist; (14) Lifetime history of prior clinical treatment with TMS; (15) Serious risk of suicide or homicide; (16) Unable/unwilling to follow the study procedures; (17) History of intractable migraine; (18) Assessed to be at risk for alcohol or opioid withdrawal.
Locations

Brain Imaging Center (BIC) - Scan Read
CTRC Inpatient
Department Specific Free Standing Clinic

Principal Investigator
Photograph of Joseph Sakai

Joseph Sakai

Study ID

Protocol Number: 23-1044

More information available at ClinicalTrials.gov: NCT06320366

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