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

Overview

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

Interventions

• Behavioral EFT
  Participants will identify three personalized and rewarding future events not related to drug use that take place 1 week, 1 month, and 6 months in the future. Participants will be asked to rate the vividness of each personalized future positive event on a 5-pt Likert scale.A brief and personalized EFT prompt will be created for each future event . Personalized EFT prompts will be presented during delay discounting and MA demand assessments following EFT training. Participants will also receive d
• Device high frequency rTMS
  TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling . For dlPFC, we will measure position F3. The first session will begin with the acquisition of the resting motor threshold on the contralateral hand. Intermittent theta burst stimulation (iTBS) (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the resting motor threshold (RMT) and will last \~3 minutes. Participants will rec
• Device sham frequency rTMS
  Participants will receive sham TMS to the dlPFC. They may feel the TMS from the A/P coil electrodes, but there will not be any real stimulation of the brain.

Primary outcome measures

• Rate of delay discounting as assessed by the 5-Trial adjusting Delay Discounting Task [Time frame: before TMS+EFT, after TMS+EFT, 7-day follow-up]
• Change in MA Demand as assessed by the Drug Purchasing Task [Time frame: before TMS+EFT, after TMS+EFT, 7-day follow-up]
• EFT Vividness as assessed by the Vividness Scale [Time frame: measured during EFT training on study day 1]
• EFT Engagement as assessed by the Engagement Scale [Time frame: 7-day follow-up]

Secondary outcome measures (4)

• Change in prospective memory as assessed by the Prospective and Retrospective Memory Questionnaire (PRMQ) [Time frame: before TMS+EFT, after TMS+EFT, 7-day follow-up]
• Change in prospective memory (PM) as assessed by the behavioral PM task [Time frame: before TMS+EFT, after TMS+EFT, 7-day follow-up]
• Number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method [Time frame: 7-day follow-up]
• Amount of Methamphetamine used in grams as assessed by the time line follow back (TLFB) method [Time frame: 7-day follow-up]

Eligibility criteria

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:

• Structured Clinical Interview for DSM-5 (SCID-5)
• Columbia-Suicide Severity Rating Scale (C-SSRS) Screening - Answers YES to Questions 3, 4, 5, or 6
• 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:

• clozapine
• chlorpromazine
• bupropion
• clomipramine hydrochloride
• amoxapine
• maprotiline hydrochloride
• diphenhydramine
• stimulants other than methamphetamine including the following: Dextroamphetamine and amphetamine, Dextroamphetamine, Lisdexamfetamine dimesylate, Cocaine, Methylphenidate,
• tramadol
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06712446 · HSC-MS-24-0886

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗