Use of Transcranial Magnetic Stimulation to Reduce Craving for Individuals With Opioid Use Disorder Taking Buprenorphine

February 28, 2022 updated by: Heather Burrell Ward, Brigham and Women's Hospital
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. In this study, individuals will receive 10 sessions of TMS (twice daily for 5 days). The investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. Investigators will enroll subjects aged 18-65 years old who are currently in treatment with buprenorphine for opioid use disorder. Included subjects will have initiated treatment with buprenorphine in the last 3 months, be able to read, write, and understand English, and, if female, agree to use contraception. Subjects will be excluded if they have a history of bipolar or psychotic illness, current depression, use substances other than opioids, take medications that lower seizure threshold or impair neuroplasticity, have chronic pain, have a history of seizure or any other uncontrolled medical issue, or have a device or ferromagnetic implant in the head or neck. Enrolled subjects will receive 10 (twice daily for 5 days) sessions of active TMS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (L DLPFC) on consecutive weekdays. Investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment completion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18-65 years old
  • Initiated treatment with buprenorphine for opioid use disorder within the last 3 months
  • Be able to understand, read and write English.
  • If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) during the study treatment period.

Exclusion Criteria:

  • Lifetime history of bipolar disorder or psychotic disorder,
  • Current depression as rated by PHQ-9 ≥ 20 (Kroenke, Spitzer, and Williams 2001, Suzuki et al. 2015)
  • Moderate chronic pain (pain intensity rated ≥ 40 on 100-point VAS lasting at least 6 months (Stein et al. 2015)
  • History of alcohol use disorder as rated by AUDIT-C ≥ 4 (at risk) (Babor et al. 2001)
  • History of complicated withdrawal from alcohol (i.e. delirium tremens, seizure)
  • Substance use disorder in the past year (other than opioid or nicotine), as assessed by drug screens,
  • Neurologic disease including stroke, seizure, migraine, or severe head injury
  • Major medical conditions that are not well-controlled or under the care of a physician
  • Device (i.e. pacemaker, cochlear prosthesis, neurostimulator, intraocular metallic fragments) or ferromagnetic implant above the neck (within 30 cm of coil),
  • Medication that lowers seizure threshold (i.e. immediate release bupropion, psychostimulants, tricyclic antidepressants) or impairs neuroplasticity (i.e. benzodiazepines)
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open-Label Active TMS
All subjects will receive open-label treatment with active Transcranial Magnetic Stimulation (TMS)
Device: Transcranial Magnetic Stimulation
TMS is a form of noninvasive brain stimulation. An external electromagnetic coil is placed on the head, and a large current is passed through an insulated wire coil held flat on the surface of a subject's scalp in a fraction of a millisecond. This pulse of current induces a weak electrical current within the surface brain cortex. Repetitive trains of TMS pulses (repetitive TMS or rTMS) can transiently modulate corticospinal excitability following the rTMS train. When current is delivered at high frequency (10 Hz), it may simultaneously increase the activity of the brain at this site. In this study, individuals will receive 10 treatments with intermittent theta burst stimulation (twice daily for 5 days).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cue-Induced Craving, as measured by 0-100 Visual Analog Scale
Time Frame: End of TMS Treatments (1 week)
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
End of TMS Treatments (1 week)
Drug Craving, as measured by 0-100 Visual Analog Scale
Time Frame: End of TMS Treatments (1 week)
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
End of TMS Treatments (1 week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
Time Frame: End of TMS Treatments (1 week)
Timeline Followback calendar, which measures days of opioid use over the past 2 weeks
End of TMS Treatments (1 week)
Retention in Buprenorphine Treatment
Time Frame: End of TMS Treatments (1 week)
Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments
End of TMS Treatments (1 week)
Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Time Frame: End of TMS Treatments (1 week)
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms
End of TMS Treatments (1 week)
Drug Craving, as measured by 0-100 Visual Analog Scale
Time Frame: 1-2 weeks after completion of TMS treatments
Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)
1-2 weeks after completion of TMS treatments
Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
Time Frame: 1-2 weeks after completion of TMS treatments
Timeline Followback calendar, which measures days of opioid use over the past month
1-2 weeks after completion of TMS treatments
Retention in Buprenorphine Treatment
Time Frame: 1-2 weeks after completion of TMS treatments
Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments
1-2 weeks after completion of TMS treatments
Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
Time Frame: 1-2 weeks after completion of TMS treatments
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms
1-2 weeks after completion of TMS treatments
Neuropsychologic Testing Battery
Time Frame: End of TMS treatment (1 week)
Penn Computerized Neuropsychologic Battery
End of TMS treatment (1 week)
Impulsivity
Time Frame: End of TMS treatment (1 week)
Barratt Impulsivity Scale
End of TMS treatment (1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather B Ward, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100313439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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