A Pilot Study of Transcranial Magnetic Stimulation Plus Episodic Future Thinking for Methamphetamine Use Disorder

The University of Texas System (UT)

Status

Enrolling

Conditions

Methamphetamine Use Disorder

Treatments

Device: high frequency rTMS

Behavioral: EFT

Device: sham frequency rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT06712446

HSC-MS-24-0886

Details and patient eligibility

About

The purpose of this study is to assess impact of repetitive transcranial magnetic stimulation (rTMS)+Episodic Future Thinking (EFT) vs. sham rTMS+EFT on delay discounting and methamphetamine (MA) demand, on vividness of future positive events during EFT training and on frequency of episodic thinking during the week following EFT training

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for primary methamphetamine use disorder
Be fluent in English and able to understand the consent form

Exclusion criteria

Current DSM-5 diagnosis for any illicit substance use disorder other than methamphetamine and marijuana
Current DSM-5 diagnosis of moderate or greater severity for alcohol and marijuana use disorder
In the opinion of the PI, the presence of any medical, neurological, psychiatric (e.g., psychotic or bipolar disorder), or physical condition, disease, or illness that, may: (a) compromise, interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
Has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
1. Structured Clinical Interview for DSM-5 (SCID-5)
2. Columbia-Suicide Severity Rating Scale (C-SSRS) Screening - Answers YES to Questions 3, 4, 5, or 6
3. Assault & homicidal danger assessment tool - Key to danger >1
Medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps, electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
History of brain surgery
History of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
Moderate-to-severe heart disease
History of stroke
Is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:
1. clozapine
2. chlorpromazine
3. bupropion
4. clomipramine hydrochloride
5. amoxapine
6. maprotiline hydrochloride
7. diphenhydramine
8. stimulants other than methamphetamine including the following: Dextroamphetamine and amphetamine, Dextroamphetamine, Lisdexamfetamine dimesylate, Cocaine, Methylphenidate,
9. tramadol
10. isoniazid
Personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
Serious head injury with loss of consciousness
Impending incarceration
Pregnant or nursing females
Inability to read, write, or speak English
For adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)