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

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • 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

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
Intervention / Treatment
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

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

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

Brigham and Women's Hospital

Investigators

  • 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)

January 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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