RECRUITING

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.

Official Title

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Quick Facts

Study Start:2024-09-03

Study Completion:2028-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06320366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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; 7. Adequate English proficiency for study consent, and completion of the study instruments.	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.

Inclusion Criteria

Exclusion 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;
7. Adequate English proficiency for study consent, and completion of the study instruments.

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.

Contacts and Locations

Study Contact

Joseph T Sakai, MD

CONTACT

303-724-7402

joseph.sakai@cuanschtz.edu

Kristen M Raymond, BA

CONTACT

303-724-3196

kristen.raymond@cuanschutz.edu

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03

Study Completion Date2028-05-31

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2028-05-31

Terms related to this study

Additional Relevant MeSH Terms

Methamphetamine Use Disorder