University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Joseph T Sakai, MD
CONTACT
Joseph T Sakai, MD
PRINCIPAL_INVESTIGATOR
Kristen M Raymond, BA
CONTACT
NCT Number: NCT06320366
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.
Interested in participating?
Request Info21 year–65 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
Joseph T Sakai, MD
CONTACT
Joseph T Sakai, MD
PRINCIPAL_INVESTIGATOR
Kristen M Raymond, BA
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure.
Time frame: 5 days
Proportion completing at least 20 TMS session - sham vs. active
Time frame: 12 weeks
Incidence of study emergent adverse events - sham vs. active
Time frame: 12 weeks
Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen.
Time frame: 12 weeks
Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview.
Time frame: 12 weeks
Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen
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.
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.
Time frame: Pre- and Post- TMS stimulation in week 1
Cue craving data will be collected pre- and post-TMS stimulation in week 1
Time frame: Pre- and Post- TMS stimulation in week 1
Resting state data will be collected pre- and post-TMS stimulation in week 1
Contact information is provided by the study sponsor or research team.
Joseph T Sakai, MD
CONTACT
Kristen M Raymond, BA
CONTACT
University of Colorado, Denver
Other
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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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