rTMS for Stimulant Use Disorders (CTN-0108)
Primary Purpose
Cocaine Use Disorder, Methamphetamine Abuse, Cocaine Dependence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sham (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Use Disorder focused on measuring Stimulant, Cocaine, Methamphetamine, Repetitive Transcranial Magnetic Stimulation, rTMS
Eligibility 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.
Sites / Locations
- Wake Forest
- Medical University of South CarolinaRecruiting
- University of Texas SouthwesternRecruiting
- University of Texas Health Science Center San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
rTMS
Sham (Placebo)
Arm Description
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Outcomes
Primary Outcome Measures
Percentage of participants who receive at least 20 sessions of rTMS/sham over the treatment period.
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
Percent of negative UDS from weekly UDS
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.
Full Information
NCT ID
NCT04907357
First Posted
May 25, 2021
Last Updated
October 2, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04907357
Brief Title
rTMS for Stimulant Use Disorders
Acronym
CTN-0108
Official Title
rTMS for Stimulant Use Disorders (CTN-0108)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Use Disorder, Methamphetamine Abuse, Cocaine Dependence, Methamphetamine Dependence, Stimulant Use, Stimulant Abuse, Methamphetamine Use Disorder, Cocaine Abuse, Stimulant Use Disorder
Keywords
Stimulant, Cocaine, Methamphetamine, Repetitive Transcranial Magnetic Stimulation, rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blind, sham-controlled study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS
Arm Type
Active Comparator
Arm Description
Participants will receive up to 30 rTMS sessions within the 8-week treatment period.
Arm Title
Sham (Placebo)
Arm Type
Sham Comparator
Arm Description
Participants will receive up to 30 sham rTMS sessions within the 8-week treatment period.
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation, TMS
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham (Placebo)
Other Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of participants who receive at least 20 sessions of rTMS/sham over the treatment period.
Description
Treatment session attendance and completion will be tracked over the course of the study, and this record will constitute the primary feasibility outcome.
Time Frame
From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Secondary Outcome Measure Information:
Title
Percent of negative UDS from weekly UDS
Description
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.
Time Frame
From first treatment week (Week 1) to end of treatment at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda M Brunner-Jackson, MPH
Phone
843-792-0618
Email
brunnerj@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna McCauley, PhD
Phone
843-792-3922
Email
mccaule@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen T Brady, MD PHD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madhukar Trivedi, MD
Organizational Affiliation
University of Texas South Western
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Individual Site Status
Completed
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Herron
Phone
843-214-4496
Email
herronal@musc.edu
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Jha, MD
Phone
214-648-7364
Email
manish.jha@utsouthwestern.edu
Facility Name
University of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://datashare.nida.nih.gov
Learn more about this trial
rTMS for Stimulant Use Disorders
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