Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06320366
Status
Recruiting
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Conditions

  • Methamphetamine Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Tolerability [ Time Frame: 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Joseph T Sakai, MD
[email protected]
303-724-7402
Kristen M Raymond, BA
[email protected]
303-724-3196
Joseph T Sakai, MD (PRINCIPAL_INVESTIGATOR)

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