Opioid-use DisorderNCT04157062
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Opioid-use Disorder and Substance-Related Disorders, run by West Virginia University.
Trial summary
The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and craving and improving thinking skills. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opioid-use Disorder, Substance-Related Disorders, Chemically-Induced Disorders
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2021to 19 Mar 2025
- 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
- Able to provide written informed consent, and to comply with study procedures.
- Be actively enrolled in the COAT Program
- Meet DSM-V criteria for a primary OUD assessed via structured clinical interview
- Columbia-Suicide Severity Rating Scale score < 4
- Be abstinent from opioids (other than prescribed buprenorphine/naloxone) and illicit substances other than marijuana at the time of the enrollment, confirmed via urine drug screen
- Willing to practice contraception to avoid pregnancy the duration of the study
Who cannot join
- Medical conditions that preclude rTMS: including vasodepressor syncope, glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (cerebral vascular accident, transient ischemic attack), any brain lesions (such multiple sclerosis), brain injury, seizure disorder (or family history) of any type, and have cardiac pacemakers or implanted medication pumps
- DSM-V criteria for major psychiatric illness other than depression
- Major Cognitive Disorder (as evidenced by a score of <21/30 on the Mini Mental Status Exam (MMSE)
- Pregnancy
- Positive responses to the TMS Adult Safety Screen or the MRI checklist
- Intracranial metallic objects (excluding dental fillings)
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- Uncorrected visual acuity problems
- Mobility limitations
- Clinically significant EKG abnormalities (including QTc interval prolongation >450 ms in men or >480 ms in women)
- Unwillingness to abstain from prescribed drugs
- Prior rTMS treatment
- Other mental or physical conditions that, in the PI's opinion, would be inappropriate for study participation.
- Intake of one or a combination of the following drugs forms a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential:
- Imipramine, Amitriptyline, Doxepine, Nortriptyline, Maprotiline, Chlorpromazine, Clozapine, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine (MDMA, ecstasy), Phencyclidine (PCP, angel's dust), Ketamine, Gamma-hydroxybutyrate (GHB), Alcohol, Theophylline.
- The inclusion of a patient on any of the above medication will be carefully evaluated and a decision documented by the medically responsible physician. The risk is dependent on the patient's past medical history, drug dose, speed of dose increase (or decrease), history of recent medication changes or duration of treatment, and combination with other CNS active drugs.
- Recent withdrawal from one of the following drugs forms a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential:
- Alcohol, Barbiturates, Benzodiazepines, Meprobamate, Chloral hydrate
About this study
The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and craving and improving thinking skills.
Read the detailed description
The overarching goal of this study is to investigate a form of neuromodulation, rTMS, as an adjunctive treatment for OUD by evaluating the impact of rTMS on substance use, craving and inhibitory control, factors which contribute to relapse. The primary outcome will be the assessment of whether rTMS reduces substance use. Additional exploratory outcomes include the assessment of whether rTMS applied to the DLPFC provides neuromodulatory effects through the assessment of craving, inhibitory control, and functional connectivity via MRI. The targeted sample size for this open-label study, where all enrolled subjects will receive 9 sessions of active rTMS over 3 weeks.
- Conditions
- Opioid-use Disorder, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Transcranial Magnetic Stimulation
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
During the rTMS session, an electromagnetic coil is placed against the subjects scalp. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in memory and thinking.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive excitatory rTMS with a stimulation frequency of 10 Hz or higher. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
rTMS reduces substance use
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).
Measured: 1 - 7 weeks
Secondary outcomes (1)
rTMS applied to the DLPFC provides neuromodulatory effects
Participants will complete standardized measures of mood, drug craving, and executive function at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).
Measured: 1 - 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start30 Sep 2021 (estimated)
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Why it stopped: Research never commenced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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
- This is an open-label study for participants who have opioid use disorder (OUD) that are eligible to have repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Mahoney, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157062
- Sponsor's protocol ID
- 1907653805
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2019
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04157062
- Acronym / sponsor ID
- 1907653805
- Conditions
- Opioid-use Disorder, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorder
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research never commenced.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 8 Nov 2019 (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.
The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and craving and improving thinking skills.
Detailed description
The overarching goal of this study is to investigate a form of neuromodulation, rTMS, as an adjunctive treatment for OUD by evaluating the impact of rTMS on substance use, craving and inhibitory control, factors which contribute to relapse. The primary outcome will be the assessment of whether rTMS reduces substance use. Additional exploratory outcomes include the assessment of whether rTMS applied to the DLPFC provides neuromodulatory effects through the assessment of craving, inhibitory control, and functional connectivity via MRI. The targeted sample size for this open-label study, where all enrolled subjects will receive 9 sessions of active rTMS over 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label study for participants who have opioid use disorder (OUD) that are eligible to have repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC).
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive excitatory rTMS with a stimulation frequency of 10 Hz or higher. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent, and to comply with study procedures.
- Be actively enrolled in the COAT Program
- Meet DSM-V criteria for a primary OUD assessed via structured clinical interview
- Columbia-Suicide Severity Rating Scale score < 4
- Be abstinent from opioids (other than prescribed buprenorphine/naloxone) and illicit substances other than marijuana at the time of the enrollment, confirmed via urine drug screen
Key exclusion criteria (17 listed)
- Medical conditions that preclude rTMS: including vasodepressor syncope, glaucoma, increased intracranial pressure, cardiac disease, migraine disorder, cerebral vascular events (cerebral vascular accident, transient ischemic attack), any brain lesions (such multiple sclerosis), brain injury, seizure disorder (or family history) of any type, and have cardiac pacemakers or implanted medication pumps
- DSM-V criteria for major psychiatric illness other than depression
- Major Cognitive Disorder (as evidenced by a score of <21/30 on the Mini Mental Status Exam (MMSE)
- Pregnancy
- Positive responses to the TMS Adult Safety Screen or the MRI checklist
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)During the rTMS session, an electromagnetic coil is placed against the subjects scalp. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in memory and thinking. | Device | Study Group |
Primary outcome
rTMS reduces substance use
Time frame: 1 - 7 weeks
Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography at screening, baseline, enrollment (3 times per week for 3 weeks), and follow-up phases (weekly for 4 weeks).
1 secondary outcome
rTMS applied to the DLPFC provides neuromodulatory effects
Time frame: 1 - 7 weeks
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 10 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Opioid-use Disorder and Substance-Related Disorders, run by West Virginia University.
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 6 inclusion and 17 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
rTMS reduces substance use (time frame: 1 - 7 weeks). 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 10 Apr 2025.