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| ID | Type | Description | Link |
|---|---|---|---|
| K24DA058882 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham TMS | Placebo Comparator | 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. |
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| Active TMS | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | Proportion completing at least 20 TMS session - sham vs. active | 5 days |
| Study emergent adverse events | Incidence of study emergent adverse events - sham vs. active | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weeks of continuous abstinence | Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen. | 12 weeks |
| Days of methamphetamine use | Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph T Sakai, MD | Contact | 303-724-7402 | joseph.sakai@cuanschtz.edu | |
| Kristen M Raymond, BA | Contact | 303-724-3196 | kristen.raymond@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
No plan to share IPD.
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Sham vs. real Transcranial Magnetic Stimulation (TMS)
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Participant and all study personnel are blinded.
| Active TMS | Device | The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure. |
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| 12 weeks |
| Time to first methamphetamine use | Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen | 12 weeks |
| Methamphetamine craving | 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. | 12 weeks |
| Methamphetamine craving on visual analog scale | Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving. | 12 weeks |
| MRI cue craving | Cue craving data will be collected pre- and post-TMS stimulation in week 1 | Pre- and Post- TMS stimulation in week 1 |
| MRI resting state | Resting state data will be collected pre- and post-TMS stimulation in week 1 | Pre- and Post- TMS stimulation in week 1 |