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NCT Number: NCT06712446

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EFT

Behavioral

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 daily text/email messages with these prompts, reminding them to engage in EFT, vividly reexperience their future events, over the week following EFT training.

High frequency rTMS

Device

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 receive 2 sessions of iTBS to the dlPFC brain region with a 15-20-minute interval between sessions

sham frequency rTMS

Device

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 outcomes

  1. 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

    This 5 item questionnaire measures the extent to which participants devalue a reward as the delay to its receipt increases.This task presents choices between $500 now vs. $1,000 after a delay.The discount rate k quantifies how rapidly the value of a delayed reward decreases with time.Low k Indicates patience or low impulsivity - greater willingness to wait for larger rewards.High k Indicates impatience or high impulsivity - preference for immediate rewards over delayed ones.

  2. Change in MA Demand as assessed by the Drug Purchasing Task

    Time frame: before TMS+EFT, after TMS+EFT, 7-day follow-up

    MA demand will be assessed by asking participants how many grams of MA they would purchase to use over the course of a weekend (Friday night to Sunday night) as a function of increasing price ($0 to $10000) Demand is the maximum quantity of Methamphetamine consumed if the drug was free measured in grams or dollar amount

  3. EFT Vividness as assessed by the Vividness Scale

    Time frame: measured during EFT training on study day 1

    This is a single item questionnaire and is scored on a 5-point Likert scale from 1(not vivid at all) to 5( extremely vivid) for a maximum score of 5, higher score indicating more vivid outcome

  4. EFT Engagement as assessed by the Engagement Scale

    Time frame: 7-day follow-up

    This is a single item questionnaire and is scored on a 4-point Likert scale 1-4 asking how often each individual engaged in EFT (i.e., every day, most days, some days, no days), higher score indicating more engagement

Secondary outcomes

  1. 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

    This is a 16 item questionnaire and each is scored on a 5-point Likert scale from 1(never) to 5(very often) for a maximum score of 80, higher score indicating better outcome

  2. Change in prospective memory (PM) as assessed by the behavioral PM task

    Time frame: before TMS+EFT, after TMS+EFT, 7-day follow-up

    The percentage of correct target identifications on the PM task

  3. Number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method

    Time frame: 7-day follow-up

  4. Amount of Methamphetamine used in grams as assessed by the time line follow back (TLFB) method

    Time frame: 7-day follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Webber, PhD

CONTACT

[email protected]

713-486-2723

Jessica Vincent

CONTACT

[email protected]

713-486-2645

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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