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Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

ConditionMethamphetamine Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Colorado, Denver

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Sham TMSPlacebo comparator 1 intervention
Group B: Active TMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Tolerability

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

Time frame
5 days
2

Study emergent adverse events

Incidence of study emergent adverse events - sham vs. active

Time frame
12 weeks

Secondary outcomes

1

Weeks of continuous abstinence

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

Time frame
12 weeks
2

Days of methamphetamine use

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

Time frame
12 weeks
3

Time to first methamphetamine use

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

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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