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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
highfrequency rTMS+EFT
  • 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 daily text/email messages with these prompts, reminding them to engage in EFT, vividly reexperience their future events, over the week following EFT training.
  • 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 receive 2 sessions of iTBS to the dlPFC brain region with a 15-20-minute interval between sessions
Sham Comparator
sham rTMS+EFT
  • 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 daily text/email messages with these prompts, reminding them to engage in EFT, vividly reexperience their future events, over the week following EFT training.
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Heather Webber, PhD
713-486-2723
Heather.E.Webber@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Heather Webber, PhD
713-486-2723
Heather.E.Webber@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.