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

NCT ID: NCT06712446

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Methamphetamine Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

highfrequency rTMS+EFT

Group Type EXPERIMENTAL

EFT

Intervention Type 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

Intervention Type 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 rTMS+EFT

Group Type SHAM_COMPARATOR

EFT

Intervention Type 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.

sham frequency rTMS

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heather E. Webber, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather Webber, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Heather Webber, PhD

Role: CONTACT

713-486-2723

Jessica Vincent

Role: CONTACT

713-486-2645

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Heather Webber, PhD

Role: primary

713-486-2723

Jessica Vincent

Role: backup

713-486-2645

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-24-0886

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

rTMS for Stimulant Use Disorders
NCT04907357 COMPLETED NA