Methamphetamine AbuseNCT04883021
A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorders
A study testing Dual Target Theta Burst Stimulation in people with Methamphetamine Abuse, run by University of New Mexico at 1 site in United States.
Trial summary
We propose a single-arm clinical trial, with historical controls as a comparison group for select outcomes. Subjects with MAUD will receive 16 sessions of dual-target theta burst stimulation to the DLPFC and MPFC over 4 weeks. We will follow outcomes for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- Dual Target Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Age less than 18 years (TMS not studied in pediatric population)
- 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, bupropion, or stimulants.
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.
- Legal or mental incompetency, or inability to consent to study.
- Unstable medical illness.
Show all 23Show fewer
- 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.
- Inability to complete the protocol, namely, inability to independently attend all study visits and TMS sessions on time.
- Prisoner
- 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 (MRI contraindicated during pregnancy)
- Unable to understand English (behavioral tests of impulsivity are only in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
About this study
We propose a single-arm clinical trial, with historical controls as a comparison group for select outcomes. Subjects with MAUD will receive 16 sessions of dual-target theta burst stimulation to the DLPFC and MPFC over 4 weeks. We will follow outcomes for 12 weeks. Outcomes include treatment retention, craving, self-reported MA or stimulant use, urine drug screen results, depressive symptoms, anxiety symptoms, sleep quality, quality of life, response inhibition, and functional connectivity. Magnetic resonance imaging (MRI) to measure functional connectivity at baseline and four weeks.
Read the detailed description
Methamphetamine (MA) use can cause many serious adverse health consequences and is an important public health issue in Iowa, New Mexico, and Utah. In the 2017 Treatment Episode Data Set, 26% of substance use disorder treatment admissions from these states involved MA as the primary substance. MA-involved overdose deaths have been increasingly common in these states. Treatment for MA use disorder (MAUD) is primarily psychosocial. Rates of treatment induction and retention are poor, and relapse rates are high. There is a pressing need to identify effective interventions that enhance psychosocial treatments.
Transcranial magnetic stimulation (TMS) using either high frequency stimulation or intermittent theta burst stimulation is a non-invasive brain stimulation technique that effectively treats major depressive disorder and is considered safe, well-tolerated, and potent. TMS has increasingly been studied to treat addiction. The dorsolateral prefrontal cortex (DLPFC), a brain region implicated in regulatory processes related to executive function, emotion, motivation, and craving, is a common target for TMS. DLPFC stimulation using high frequency repetitive TMS has reduced craving in many studies of addictive disorders, including cocaine and MAUD. In addition to the DLPFC target, emerging evidence indicates that continuous theta burst stimulation (cTBS) delivered to the medial prefontal cortex (MPFC) during drug cue activation reduced craving and related brain activity in cocaine users. Despite these encouraging findings, no trials have reported on the efficacy of TMS for reducing MA use or preventing relapse. Clinical research on TMS for MAUD is sparse in the United States, and the limited studies of TMS in MAUD have been in experimental or closed treatment settings where effects on actual MA use are difficult to evaluate.
We are proposing a pilot study in 8 people with MAUD engaged in psychosocial treatment to explore the effects and tolerability of a four-week treatment protocol combining intermittent theta burst stimulation of the DLPFC with cTBS targeting the MPFC (dual-target TMS). We expect that this combined approach will enhance executive function and inhibitory control and reduce craving through separate but related mechanisms. We will evaluate clinical outcomes including symptoms and substance use, changes in functional connectivity measured via MRI and their relationship to treatment response, and changes in impulsivity as measured by performance on a response inhibition task. This project has the following specific aims:
Aim 1: Characterize changes in craving, depressive symptoms, anxiety symptoms, sleep quality, quality of life, and MA or other stimulant use over four weeks of dual-target TMS and eight weeks of subsequent follow-up.
Aim 2: Estimate changes in functional connectivity in the brain and response inhibition and selective attention in people with MAUD after four weeks of dual-target TMS.
Aim 3: Evaluate retention in the study to establish feasibility and tolerability of the protocol.
Aim 4: Compare retention in psychosocial treatment and positive urine drug screens in study participants compared to matched historical controls.
- Conditions
- Methamphetamine Abuse
- Being tested
- Dual Target Theta Burst Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Target Theta Burst StimulationDevice
TMS treatment will be provided daily for 5 days, then daily for 5 days in week 2, and three times per week (Monday, Wednesday, Friday) in weeks 3 and 4.
Treatment targeting will occur at the Beam F3 and FP1 scalp regions as defined by the 10-20 EEG system and previous publications. A Magventure MagPro X100 figure-8 coil with theta burst capabilities will be used to deliver the stimulus, including intermittent theta burst stimulation to the DLPFC (2 seconds of 50-Hz triplets delivered at 5 Hz, 8 seconds intertrain interval, 600 total pulses) and continuous theta burst to the MPFC (continuous 50-Hz stimulation triplets, 600 pulses). Stimulation will be delivered at 110% of the resting motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| Dual Target Theta Burst Stimulation | Experimental | The TMS intervention is open-label dual-target theta burst stimulation delivered in sequential fashion to the DLPFC and the MPFC. Receives: Device: Dual Target Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Retention in Study
Percentage of subjects who complete the 4-week TMS treatment period.
Measured: 4 week visit
Change in functional connectivity
Change in connectivity index between the dorsolateral prefrontal cortex (DLPFC) and anterior insula
Measured: 4 week visit
Change in Craving
Change in the Brief Substance Craving Scale Score
Measured: 4 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Aug 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm prospective cohort study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Utah
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883021
- Sponsor's protocol ID
- UNM HRRC# 20-077
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorders
- ClinicalTrials.gov ID
- NCT04883021
- Acronym / sponsor ID
- UNM HRRC# 20-077
- Conditions
- Methamphetamine Abuse
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- University of Iowa, University of Utah
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a single-arm clinical trial, with historical controls as a comparison group for select outcomes. Subjects with MAUD will receive 16 sessions of dual-target theta burst stimulation to the DLPFC and MPFC over 4 weeks. We will follow outcomes for 12 weeks. Outcomes include treatment retention, craving, self-reported MA or stimulant use, urine drug screen results, depressive symptoms, anxiety symptoms, sleep quality, quality of life, response inhibition, and functional connectivity. Magnetic resonance imaging (MRI) to measure functional connectivity at baseline and four weeks.
Detailed description
Methamphetamine (MA) use can cause many serious adverse health consequences and is an important public health issue in Iowa, New Mexico, and Utah. In the 2017 Treatment Episode Data Set, 26% of substance use disorder treatment admissions from these states involved MA as the primary substance. MA-involved overdose deaths have been increasingly common in these states. Treatment for MA use disorder (MAUD) is primarily psychosocial. Rates of treatment induction and retention are poor, and relapse rates are high. There is a pressing need to identify effective interventions that enhance psychosocial treatments.
Transcranial magnetic stimulation (TMS) using either high frequency stimulation or intermittent theta burst stimulation is a non-invasive brain stimulation technique that effectively treats major depressive disorder and is considered safe, well-tolerated, and potent. TMS has increasingly been studied to treat addiction. The dorsolateral prefrontal cortex (DLPFC), a brain region implicated in regulatory processes related to executive function, emotion, motivation, and craving, is a common target for TMS. DLPFC stimulation using high frequency repetitive TMS has reduced craving in many studies of addictive disorders, including cocaine and MAUD. In addition to the DLPFC target, emerging evidence indicates that continuous theta burst stimulation (cTBS) delivered to the medial prefontal cortex (MPFC) during drug cue activation reduced craving and related brain activity in cocaine users. Despite these encouraging findings, no trials have reported on the efficacy of TMS for reducing MA use or preventing relapse. Clinical research on TMS for MAUD is sparse in the United States, and the limited studies of TMS in MAUD have been in experimental or closed treatment settings where effects on actual MA use are difficult to evaluate.
We are proposing a pilot study in 8 people with MAUD engaged in psychosocial treatment to explore the effects and tolerability of a four-week treatment protocol combining intermittent theta burst stimulation of the DLPFC with cTBS targeting the MPFC (dual-target TMS). We expect that this combined approach will enhance executive function and inhibitory control and reduce craving through separate but related mechanisms. We will evaluate clinical outcomes including symptoms and substance use, changes in functional connectivity measured via MRI and their relationship to treatment response, and changes in impulsivity as measured by performance on a response inhibition task. This project has the following specific aims:
Aim 1: Characterize changes in craving, depressive symptoms, anxiety symptoms, sleep quality, quality of life, and MA or other stimulant use over four weeks of dual-target TMS and eight weeks of subsequent follow-up.
Aim 2: Estimate changes in functional connectivity in the brain and response inhibition and selective attention in people with MAUD after four weeks of dual-target TMS.
Aim 3: Evaluate retention in the study to establish feasibility and tolerability of the protocol.
Aim 4: Compare retention in psychosocial treatment and positive urine drug screens in study participants compared to matched historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Dual Target Theta Burst Stimulation | Experimental | Device: Dual Target Theta Burst StimulationThe TMS intervention is open-label dual-target theta burst stimulation delivered in sequential fashion to the DLPFC and the MPFC. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- Age less than 18 years (TMS not studied in pediatric population)
- 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, bupropion, or stimulants.
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.
- Legal or mental incompetency, or inability to consent to study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Target Theta Burst StimulationTMS treatment will be provided daily for 5 days, then daily for 5 days in week 2, and three times per week (Monday, Wednesday, Friday) in weeks 3 and 4. Treatment targeting will occur at the Beam F3 and FP1 scalp regions as defined by the 10-20 EEG system and previous publications. A Magventure MagPro X100 figure-8 coil with theta burst capabilities will be used to deliver the stimulus, including intermittent theta burst stimulation to the DLPFC (2 seconds of 50-Hz triplets delivered at 5 Hz, 8 seconds intertrain interval, 600 total pulses) and continuous theta burst to the MPFC (continuous 50-Hz stimulation triplets, 600 pulses). Stimulation will be delivered at 110% of the resting motor threshold. | Device | Dual Target Theta Burst Stimulation |
Primary outcome
Rate of Retention in Study
Time frame: 4 week visit
Percentage of subjects who complete the 4-week TMS treatment period.
Change in functional connectivity
Time frame: 4 week visit
Change in connectivity index between the dorsolateral prefrontal cortex (DLPFC) and anterior insula
Change in Craving
Time frame: 4 week visit
Change in the Brief Substance Craving Scale Score
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Target Theta Burst Stimulation in people with Methamphetamine Abuse, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Retention in Study (time frame: 4 week visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.