Clinical trial NCT04907357: rTMS for Stimulant Use Disorders
Official title: rTMS for Stimulant Use Disorders (CTN-0108)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-05-28
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, sham-controlled study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Who Receive at Least 20 Sessions of rTMS/Sham Over the Treatment Period.
timeFrame: From first treatment session (Week 1, first study visit) to end of treatment at 8 weeks
Secondary outcomes:
measure: Negative UDS From Weekly UDS
timeFrame: From first treatment week (Week 1) to end of treatment at 8 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: Medical University of South Carolina
name: Kathleen T Brady, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas South Western
name: Madhukar Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References: