Clinical trial NCT06712446: A Pilot Study of Transcranial Magnetic Stimulation Plus Episodic Future Thinking for Methamphetamine Use Disorder
Official title: A Pilot Study of Transcranial Magnetic Stimulation Plus Episodic Future Thinking for Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Methamphetamine Use Disorder
Keywords: delay discounting
methamphetamine
brain stimulation
episodic future thinking
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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:

  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)

Primary outcomes:
measure: Rate of delay discounting as assessed by the 5-Trial adjusting Delay Discounting Task
timeFrame: before TMS+EFT, after TMS+EFT, 7-day follow-up
measure: Change in MA Demand as assessed by the Drug Purchasing Task
timeFrame: before TMS+EFT, after TMS+EFT, 7-day follow-up
measure: EFT Vividness as assessed by the Vividness Scale
timeFrame: measured during EFT training on study day 1
measure: EFT Engagement as assessed by the Engagement Scale
timeFrame: 7-day follow-up
Secondary outcomes:
measure: Change in prospective memory as assessed by the Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: before TMS+EFT, after TMS+EFT, 7-day follow-up
measure: Change in prospective memory (PM) as assessed by the behavioral PM task
timeFrame: before TMS+EFT, after TMS+EFT, 7-day follow-up
measure: Number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method
timeFrame: 7-day follow-up
measure: Amount of Methamphetamine used in grams as assessed by the time line follow back (TLFB) method
timeFrame: 7-day follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Heather Webber, PhD
role: PRINCIPAL_INVESTIGATOR
References: