N/A
N=11
Pilot TMS for Methamphetamine Use Disorder
Stimulant Dependence · Methamphetamine-dependence · Addiction, Drug
Bottom Line
View on ClinicalTrials.gov: NCT04449055 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Jan 2026
Primary outcome: Primary: Retention in the Study — 28.2; 45.4 Days — p=0.1760
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation--DPFC first, MPFC second (Device); Transcranial Magnetic Stimulation--MPFC first, DPFC second (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ryan M. Carnahan
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention in the Study |
28.2; 45.4 | 0.1760 |
| PRIMARY Retention in Psychosocial Treatment |
NA; NA | 0.3711 |
| SECONDARY Functional Connectivity of the Dorsolateral Prefrontal Cortex and Anterior Insula |
-0.0437533; 0.000470725; 0.0844848; 0.0129312 | 0.1333 |
| SECONDARY Functional Connectivity Dorsolateral Prefrontal Cortex and Anterior Cingulate Cortex |
-0.0563551; 0.0542240; -0.2974375; 0.0960170 | 0.1333 |
| SECONDARY Functional Connectivity of the Medial Prefrontal Cortex and Ventral Striatum (Nucleus Accumbens) |
0.1795790; 0.0383048; -0.0576222; 0.0474714 | 0.2667 |
| SECONDARY Flanker Inhibitor Control and Attention Test, Age 12+ |
115; 97; 106; 93 | 0.6829 |
| SECONDARY Kirby Delay Discounting Questionnaire, 27 Item |
-2.9817; -3.8350; -2.7660; -3.9792 | 0.7654 |
| SECONDARY Number of Days of Stimulant Use in the Past Week (Estimated Change Per Day) |
-0.1026; -0.09523 | 0.9070 |
| SECONDARY Urine Drug Screen Positive for Stimulant |
0.8892; 0.9921 | 0.1427 |
| SECONDARY Brief Substance Craving Scale (Estimated Change in Score Per Day) |
-0.04980; -0.02411 | 0.3917 |
| SECONDARY Brief Addiction Monitor Use Subscale (Estimated Change in Score Per Day) |
-0.05848; -0.04089 | 0.3829 |
| SECONDARY Brief Addiction Monitor Risk Factors Subscale (Estimated Change in Score Per Day) |
-0.1235; -0.1066 | 0.7595 |
| SECONDARY Brief Addiction Monitor Protective Factors Subscale (Estimated Change in Score Per Day) |
-0.00530; 0.03826 | 0.3839 |
| SECONDARY Brief Addiction Monitor Satisfaction With Progress Toward Achieving Recovery Goals (Estimated Change Per Day) |
-0.01378; -0.00833 | 0.7455 |
| SECONDARY Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Estimated Change in Score Per Day) |
0.003497; 0.2160 | 0.0823 |
| SECONDARY Patient Health Questionnaire--8 Item Scale (Estimated Change in Score Per Day) |
-0.08549; -0.1328 | 0.5289 |
| SECONDARY Generalized Anxiety Disorder 7-item Scale (Estimated Change Per Day) |
-0.05545; -0.05776 | 0.9714 |
| SECONDARY Assessment of Recovery Capital (Estimated Change Per Day) |
0.09980; 0.2266 | 0.2914 |
| SECONDARY Positive and Negative Affect Scale Positive Affect Score (Estimated Change Per Day) |
-0.04983; 0.1111 | 0.0573 |
| SECONDARY Positive and Negative Affect Scale Negative Affect Score (Estimated Change Per Day) |
-0.08496; -0.07669 | 0.9250 |
| SECONDARY Pittsburgh Sleep Quality Index (Estimated Change Per Day) |
-0.08000; -0.07924 | 0.9775 |
| SECONDARY Difficulties in Emotion Regulation Scale--Short Form (Estimated Change Per Day) |
-0.1035; -0.1010 | 0.9211 |
| SECONDARY UPPS-P Impulsive Behavior Scale, 59-item Revised Version (Estimated Change Per Day) |
0.06023; -0.2392 | 0.5269 |
Summary
This is a pilot study to test the feasibility of a recruitment strategy and study protocol to examine the effects of a dual target transcranial magnetic stimulation treatment in methamphetamine use disorder. The study will test intermittent theta burst stimulation (TBS) targeting the dorsolateral prefrontal cortex (DLPFC) combined with continuous TBS targeting the medial prefrontal cortex (MPFC) in people with methamphetamine use disorder (MAUD) who are engaged in psychosocial treatment. We will randomize the order in which these treatments are delivered at each treatment session, but all subjects will receive both treatments. Intermittent TBS targeting the DLPFC is approved by the Food and Drug Administration for major depressive disorder, and continuous TBS targeting the MPFC has been studied in cocaine use disorder. We will administer this dual target TBS daily for 2 weeks, followed by three times weekly for 2 weeks, and monitor depressive symptoms, anxiety, sleep, craving, quality of life, and methamphetamine use for three months. Changes in functional connectivity of brain circuits will be evaluated with functional magnetic resonance imaging (fMRI) before and after treatment. We expect to observe changes in connectivity between the DLPFC, MPFC, and other regions implicated in addiction and impulsivity. Furthermore, we will evaluate if baseline differences in functional connectivity can be used to predict response. Psychological tests focusing on state impulsivity and risk taking will be administered, and we expect to observe reductions in these characteristics after treatment. We will test this protocol in 20 patients recruited from clinical care settings at University of Iowa Hospitals and Clinics, University of New Mexico Health System, and University of Utah Health to illustrate the feasibility of recruitment and completing the protocol, to support an external funding proposal.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with an active methamphetamine use disorder
- Is engaged in psychosocial treatment or articulates a plan to engage in psychosocial treatment for methamphetamine use disorder during the study period
- Age 18 to 60 years
- Able to consent for treatment and research participation
- English-speaking
- Receiving care from UIHC's Addiction Medicine service. This includes patients in the Crisis Stabilization Unit, seen by the inpatient consultation service, enrolling in partial hospitalization or intensive outpatient treatment, or seen in the outpatient Addiction Medicine clinics.
Exclusion Criteria
- Age less than 18 years
- Patients that are excluded during TMS assessment including: patients with epilepsy or seizure disorder, patients with implanted ferromagnetic equipment in their face or skull near the stimulation target.
- Current medical treatment with clozapine or stimulants.
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, that is deemed by research team psychiatrists not to have been drug-induced. Psychotic disorder not associated with drug use per the MINI International Neuropsychiatric Interview. Psychosis NOS, in remission, or drug-induced psychotic episodes are not exclusion criteria since these may be related to methamphetamine misuse.
- Lacks the mental capacity to provide informed consent (i.e. not able to demonstrate understanding of the risks and benefits of participation)
- Has a court appointed guardian.
- Unstable medical illness.
- Current diagnosis of neurological disorder or neurocognitive disorder.
- Prior neurosurgical procedure.
- History of seizure.
- History of ECT treatment within the past three months.
- History of any previous TMS treatment.
- Known inability to complete the protocol, as assessed by asking them if they are able to make it to all visits for this study without assistance.
MRI Exclusion criteria:
- Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
- Metal in body including bullets, shrapnel, metal slivers
- Claustrophobia
- Uncontrolled high blood pressure
- Atrial fibrillation
- Significant heart disease
- Hemodynamic instability
- Kidney disease
- Pregnant
Data sourced from ClinicalTrials.gov (NCT04449055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.