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NCT Number: NCT06320366

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

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.

Recruiting

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Unable/unwilling to follow the study procedures;
  • History of intractable migraine;
  • Assessed to be at risk for alcohol or opioid withdrawal.

Treatment and study plan

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.

active TMS

Device

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

Primary outcomes

  1. Tolerability

    Time frame: 5 days

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

  2. Study emergent adverse events

    Time frame: 12 weeks

    Incidence of study emergent adverse events - sham vs. active

Secondary outcomes

  1. Weeks of continuous abstinence

    Time frame: 12 weeks

    Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen.

  2. Days of methamphetamine use

    Time frame: 12 weeks

    Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview.

  3. Time to first methamphetamine use

    Time frame: 12 weeks

    Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen

  4. Methamphetamine craving

    Time frame: 12 weeks

    Craving as measured on the Stimulant Craving Questionnaire-Brief - sham vs. active. Each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. The investigators will average all 10 items as the total score, with higher scores indicating greater levels of craving.

  5. Methamphetamine craving on visual analog scale

    Time frame: 12 weeks

    Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving.

  6. MRI cue craving

    Time frame: Pre- and Post- TMS stimulation in week 1

    Cue craving data will be collected pre- and post-TMS stimulation in week 1

  7. MRI resting state

    Time frame: Pre- and Post- TMS stimulation in week 1

    Resting state data will be collected pre- and post-TMS stimulation in week 1

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph T Sakai, MD

CONTACT

[email protected]

303-724-7402

Kristen M Raymond, BA

CONTACT

[email protected]

303-724-3196

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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