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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kathleen Brady, MD, PhD, Medical University of South Carolina

Brief Summary:
The purpose of the study is to determine feasibility of repetitive transcranial magnetic stimulation (rTMS) for individuals with moderate to severe cocaine or methamphetamine use disorder (CUD/MUD). Potential participants will be age 18-65, and interested in cutting down or stopping use. Participants will be randomized to one of two groups; groups will receive rTMS or sham rTMS (placebo) over the course of an 8-week treatment period, and complete follow-up assessments at the end of treatment, 12, and 16 weeks post-randomization.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a double-blind, sham-controlled study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: rTMS
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
Device: rTMS
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).
Other Names:
  • Repetitive Transcranial Magnetic Stimulation
  • TMS

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65, inclusive
  • Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) over the past 12 months (as determined by DSM-5 diagnostic criteria).
  • Have used cocaine or methamphetamine on at least 10 of the last 30 days (based on Timeline Follow-Back).
  • Be interested in decreasing cocaine and/or methamphetamine use.
  • If female, willing to use appropriate birth control method during the treatment phase of the study.
  • Be able to understand the study procedures and provide written informed consent to participate in the study.
  • If prescribed benzodiazepines or anticonvulsants, must be on a stable dose for at least 4 weeks prior to consent.

Exclusion Criteria:

  • A Diagnostic and Statistical Manual (DSM-5) diagnosis of moderate or severe SUD of any substance other than cocaine or methamphetamine based on DSM-5.
  • History of a serious medical disorder that, in the opinion of the Medical Clinician, would make it unsafe to participate in the study or may prevent collection of study data.
  • Is currently engaged in formal SUD treatment.
  • Documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
  • Documented history of brain lesion(s) and/or tumor(s).
  • Metal implants or non-removable metal objects above the waist.
  • Currently pregnant.
  • Lifetime history of prior clinical treatment with TMS.
  • Current or lifetime bipolar disorder.
  • Current psychotic disorder or psychotic depression.
  • Serious risk of homicide or suicide.
  • Are a prisoner or in police custody at the time of eligibility screening.
  • Previously randomized as a participant in the study.
  • Planned admission to a residential treatment facility or other formal SUD treatment program.
  • Unwilling or unable to follow study procedures.

Information from the National Library of Medicine

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


Contacts
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Contact: Brenda M Brunner-Jackson, MPH 843-792-0618 brunnerj@musc.edu
Contact: Jenna McCauley, PhD 843-792-3922 mccaule@musc.edu

Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27101
Contact: Colleen Hanlon, PhD    336-713-7848    chanlon@wakehealth.edu   
Contact: Hilary Smith    336-716-8649    hsmith@wakehealth.edu   
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Contact: Karen J Hartwell, MD    843-792-4606    hartwelk@musc.edu   
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Contact: Andrew Czysz, MD PHD    214-648-0177    Andrew.czysz@utsouthwestern.edu   
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   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kathleen T Brady, MD PHD Medical University of South Carolina
Principal Investigator: Madhukar Trivedi, MD University of Texas South Western
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Responsible Party: Kathleen Brady, MD, PhD, Distinguished University Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04907357    
Other Study ID Numbers: 00107688
UG1DA013727 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The lead investigator will submit coded individual level data on Clinical Trials Network (CTN) study participants to the Data Management Center contracted by National Institute on Drug Abuse (NIDA) Center for CTN. These data may include but are not limited to: demographic information, date of birth, medical history, substance use history, psychiatric history, objective measures of substance use and psychiatric status, HIV status and genetic information. Data will be submitted without information that could readily identify the study participant (i.e. We will not share medical record numbers, social security numbers or participant names or phone numbers with the Data Management Center). De-identified data will be made publicly available per the CTN's policies
Supporting Materials: Study Protocol
Time Frame: Data sets for this protocol will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first.
Access Criteria: Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
URL: https://datashare.nida.nih.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kathleen Brady, MD, PhD, Medical University of South Carolina:
Stimulant
Cocaine
Methamphetamine
Repetitive Transcranial Magnetic Stimulation
rTMS
Additional relevant MeSH terms:
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Disease
Cocaine-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders