Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

NCT06320366 | Recruiting DMC FDA Device

• 2 other identifiers: 23-1044K24DA058882
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Use Disorder

Outcome Measures

Primary Outcomes (2)

• Tolerability

  Proportion completing at least 20 TMS session - sham vs. active

  5 days

• Study emergent adverse events

  Incidence of study emergent adverse events - sham vs. active

  12 weeks

Secondary Outcomes (7)

• Weeks of continuous abstinence

  12 weeks

• Days of methamphetamine use

  12 weeks

• Time to first methamphetamine use

  12 weeks

• Methamphetamine craving

  12 weeks

• Methamphetamine craving on visual analog scale

  12 weeks

Study Arms (2)

Sham TMS

PLACEBO COMPARATOR

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.

Device: Sham TMS

Active TMS

EXPERIMENTAL

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.

Device: Active TMS

Interventions

Sham TMS 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.

Sham TMS

Active TMS DEVICE

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

Active TMS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65 years inclusive;
• Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
• By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
• Provides a urine drug screen positive for methamphetamine;
• Able to provide informed consent;
• No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
• Adequate English proficiency for study consent, and completion of the study instruments.

You may not qualify if:

• Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
• Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
• Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
• 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;
• Presence of a clinically significant abnormality on baseline MRI;
• Inability to have an MRI;
• 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);
• Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
• History of head injury with loss of consciousness for more than 15 minutes;
• Diagnosis of dementia;
• Prescribed benzodiazepines or anticonvulsants;
• Currently enrolled in formal substance use disorder treatment;
• Metal implants or non-removable metal objects above the waist;
• Lifetime history of prior clinical treatment with TMS;
• Serious risk of suicide or homicide;

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Central Study Contacts

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant and all study personnel are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sham vs. real Transcranial Magnetic Stimulation (TMS)

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)