Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

NCT ID: NCT06320366

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2028-05-31

Brief Summary

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.

Detailed Description

In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.

Conditions

Methamphetamine Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham TMS

Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks.

Group Type: PLACEBO_COMPARATOR

Sham TMS

Intervention Type: DEVICE

The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure.

Active TMS

Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks.

Group Type: EXPERIMENTAL

Active TMS

Intervention Type: DEVICE

The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.

Interventions

Sham TMS

The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure.

Intervention Type: DEVICE

Active TMS

The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.

Intervention Type: DEVICE

Eligibility Criteria

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;

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

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph T Sakai, MD

Role: CONTACT

joseph.sakai@cuanschtz.edu

303-724-7402

Kristen M Raymond, BA

Role: CONTACT

kristen.raymond@cuanschutz.edu

303-724-3196

Facility Contacts

Joseph T Sakai, MD

Role: primary

joseph.sakai@cuanschutz.edu

303-724-7402

Kristen M Raymond, BA

Role: backup

kristen.raymond@cuanschutz.edu

303-724-3196

Other Identifiers

K24DA058882

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-1044

Identifier Type: -

Identifier Source: org_study_id