rTMS for Stimulant Use Disorders (CTN-0108)
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|ClinicalTrials.gov Identifier: NCT04907357|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Use Disorder Methamphetamine Abuse Cocaine Dependence Methamphetamine Dependence Stimulant Use Stimulant Abuse Methamphetamine Use Disorder Cocaine Abuse Stimulant Use Disorder||Device: rTMS Device: Sham (Placebo)||Not Applicable|
The study will be a randomized, double-blind, sham-controlled trial comparing rTMS vs. placebo delivered over an 8-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 30 sessions of either rTMS or placebo treatments. The target minimum number of rTMS/placebo treatments is 20 treatments over 8 weeks. The secondary objective is to gather preliminary data on the efficacy of rTMS for individuals with moderate to severe CUD or MUD. Follow-up visits occur at end of treatment and at 12- and 16-weeks following randomization.
Other study procedures:
Actigraphy: To assess daily sleep quality during weeks 1-8, the ActiGraph wristband device will record, sleep latency, sleep duration, and intervals of waking during the sleep period.
Electroencephalography (EEG): EEG will be obtained after randomization and again at week 4, to explore the potential for EEG to be used as a biomarker of treatment response.
Cognitive-Behavioral Educational Intervention: Participants in both conditions (rTMS and placebo) will be encouraged to participate in a mobile app-based educational intervention based on principles of Cognitive Behavioral Therapy (CBT) for Substance Use Disorder (SUD).
Daily Assessments: Brief, electronic remote surveys will be administered to participants daily until week 16 follow-up time point and will assess use of primary substance of abuse, craving, ability to resist use, overall mood, and self-rated sleep quality.
Urine Drug Screens (UDS): UDS will be collected at screening, randomization, every treatment session, and at follow-up visits.
Urine pregnancy tests: Pregnancy testing for all female participants will be performed at screening, randomization, and monthly during the treatment period.
Physical exam: A physical exam will be performed at screening.
Questionnaires: A battery of study assessments will be completed to further inform findings regarding feasibility and effects of rTMS on individuals with stimulant use disorders.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a double-blind, sham-controlled study.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||rTMS for Stimulant Use Disorders (CTN-0108)|
|Estimated Study Start Date :||August 2021|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||December 2024|
Active Comparator: rTMS
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
Sham Comparator: Sham (Placebo)
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Device: Sham (Placebo)
Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
Other Name: Sham Repetitive Transcranial Magnetic Stimulation
- Percentage of participants who receive at least 20 sessions of rTMS/sham over the treatment period. [ Time Frame: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks ]Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
- Percent of negative UDS from weekly UDS [ Time Frame: From first treatment week (Week 1) to end of treatment at 8 weeks ]A negative UDS for participants with cocaine as primary substance would be a UDS absent of cocaine; a negative UDS for participants with methamphetamine as primary substance would be a UDS absent of methamphetamine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04907357
|Contact: Brenda M Brunner-Jackson, MPHemail@example.com|
|Contact: Jenna McCauley, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27101|
|Contact: Colleen Hanlon, PhD 336-713-7848 email@example.com|
|Contact: Hilary Smith 336-716-8649 firstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Contact: Karen J Hartwell, MD 843-792-4606 email@example.com|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|Contact: Andrew Czysz, MD PHD 214-648-0177 Andrew.firstname.lastname@example.org|
|Contact: Elizabeth Dedrick Elizabeth.Dedrick@UTSouthwestern.edu|
|University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|Contact: Melissa Martinez Martinezm50@uthscsa.edu|
|Contact: Meissa Wheeler, MS Wheelerm1@uthscsa.edu|
|Principal Investigator:||Kathleen T Brady, MD PHD||Medical University of South Carolina|
|Principal Investigator:||Madhukar Trivedi, MD||University of Texas South Western|