Actively Recruiting

Phase Not Applicable
Age: 21Years - 65Years
All Genders
NCT06320366

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Led by University of Colorado, Denver · Updated on 2025-10-03

20

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21-65 years inclusive
  • Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder
  • At least 10 days of methamphetamine use in the last month as reported by Timeline Follow Back
  • Positive urine drug screen for methamphetamine
  • Able to provide informed consent
  • No changes in psychiatric medications or medication free for at least 4 weeks before study entry
  • Adequate English proficiency for consent and study procedures
Not Eligible

You will not qualify if you...

  • Lifetime diagnosis of non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder, or bipolar disorder
  • Current DSM-5 diagnosis of drug use disorder other than stimulant, cannabis, or nicotine use disorder
  • Manic episode within past 3 years or major depressive episode within past year
  • Significant neurological disorder or medical illness including seizure history or cardiovascular disease making participation unsafe
  • Clinically significant abnormality on baseline MRI
  • Inability to undergo MRI
  • Currently pregnant, breastfeeding, or not using effective contraception if of childbearing potential
  • Active unresolved legal problems
  • History of head injury with loss of consciousness over 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
  • Prior clinical treatment with TMS
  • Serious risk of suicide or homicide
  • Unable or unwilling to follow study procedures
  • History of intractable migraine
  • Risk for alcohol or opioid withdrawal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

J

Joseph T Sakai, MD

CONTACT

K

Kristen M Raymond, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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