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

Not Applicable

Recruiting

• Conditions: Methamphetamine Use Disorder

• Registration Number: NCT06712446
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-12-02
• Study Start: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of delay discounting as assessed by the 5-Trial adjusting Delay Discounting Task	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.
Change in MA Demand as assessed by the Drug Purchasing Task	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
EFT Vividness as assessed by the Vividness Scale	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
EFT Engagement as assessed by the Engagement Scale	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 Outcome Measures

Name	Time	Method
Change in prospective memory as assessed by the Prospective and Retrospective Memory Questionnaire (PRMQ)	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
Change in prospective memory (PM) as assessed by the behavioral PM task	before TMS+EFT, after TMS+EFT, 7-day follow-up	The percentage of correct target identifications on the PM task
Number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method	7-day follow-up
Amount of Methamphetamine used in grams as assessed by the time line follow back (TLFB) method	7-day follow-up

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States