Accelerated rTMS for Substance Use Disorder and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with depression and stimulant use disorder \[including methamphetamine or cocaine use disorder (MUD/CUD)\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be aged 18-65 years, inclusive.
Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions, and be willing to comply with all study procedure instructions.
Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) or other Stimulant Use Disorder over the past 12 months (as determined by the MINI International Neuropsychiatric Interview).
Disqualifiers
Have a current pattern of alcohol, benzodiazepine, or other sedative/hypnotic use that would preclude safe participation in the study, as determined by the PI or their designee.
Have a history of a serious medical disorder that, in the opinion of the PI or their designee, would make it unsafe to participate in the study or may prevent collection of study data (e.g., disabling terminal diagnosis for which hospice care is being sought; serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy and/or is clinically stable on therapy, in the opinion of the PI or their designee, prior to study entry).
Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
Have a documented history of brain lesion(s) and/or tumor(s).
Trial design
Design model
Single group
Treatments tested in this trial
Accelerated Repetitive Transcranial Magnetic Stimulation
DeviceThe rTMS protocol implemented in this study will include approximately 10-minute long sessions of intermittent theta burst stimulation (iTBS) with at least 50 minutes in between iTBS sessions. Study participants will receive the rTMS intervention for up to 50 sessions across a three-week period. The total of 50 sessions will be administered as up to 4 sessions each day, up to 5 days per week over an up to 3-week-long period.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: rTMS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of an accelerated course of repetitive Transcranial Magnetic Stimulation (rTMS).
Feasibility will be measured by completion of at least 30 out of 50 sessions of rTMS.
Time frame
3 weeksSecondary outcomes
1
Attainment of response of rTMS intervention on stimulant use assessed by Urine Drug Screens.
Attainment of response is defined as 3 out of 5 negative urine samples for stimulants (cocaine, amphetamines), in week 3 of treatment.
Time frame
3 weeks2
Changes in stimulant craving during the 3-week treatment phase assessed by the Stimulant Craving Questionnaire (STCQ).
The Stimulant Craving Questionnaire (STCQ) is a 10-item self-report measure derived from the 10-item Cocaine Craving Questionnaire-Brief and the original 46-item Cocaine Craving Questionnaire-Now. The STCQ assesses current craving for stimulants (cocaine, methamphetamine, and other stimulants) using a seven-point scale, with answers ranging from "strongly disagree" to "agree."
Time frame
3 weeks3
Changes in stimulant craving during the 3-week treatment phase assessed by a Visual Analog Drug Craving Scale (VAS).
Craving for stimulants and other substances will be self-reported by participants on a Visual Analog Drug Craving Scale (VAS) which ranges from 0 (no craving) to 100 (most intense craving possible).
Time frame
3 weeks4
Changes in stimulant craving during the 3-week treatment phase assessed by the Cue Craving Assessment.
Current craving for stimulants will be assessed using the Cue Craving Assessment. Participants will be asked about their current craving for and ability to resist stimulants on a 0-10 scale immediately after cue exposure prior to rTMS and after the completion of each rTMS session. A "0" rating indicates the absence of craving or the absence of the ability to resist use, whereas a "10" rating indicates the highest craving or strongest ability to resist use.
Time frame
3 weeksSponsors and contacts
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Source ClinicalTrials.gov