Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Last updated: November 14, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stimulant Use Disorder

Treatment

Active TMS

Sham TMS

Clinical Study ID

NCT06320366
23-1044
K24DA058882
  • Ages 21-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thelast 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 atleast 4 weeks prior to study entry;

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

Exclusion

Exclusion Criteria:

  1. Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffectivedisorder or bipolar disorder defined by DSM-5;

  2. Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis ornicotine use disorder;

  3. Non-substance-induced manic episode within the past 3 years or major depressiveepisode in the past year;

  4. Current clinically significant neurological disorder or medical illness, includinghistory of seizures, cardiovascular disease/cardiac event, which in the opinion ofthe 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 effectivecontraception in women of childbearing age, as assessed by urine pregnancy test andself-report (participants will consent to continue effective contraceptives duringthe study);

  8. Active criminal justice involvement (i.e., any unresolved legal problems that couldjeopardize 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.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Active TMS
Phase:
Study Start date:
September 03, 2024
Estimated Completion Date:
May 31, 2028

Study 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.

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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