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

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ClinicalTrials.gov Identifier: NCT03653169
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Heather Burrell Ward, Brigham and Women's Hospital

Brief Summary:
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. The investigators will assess craving, substance use, and mood throughout the study and one-month post-treatment.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Device: Transcranial Magnetic Stimulation Not Applicable

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 sessions of active TMS to the left dorsolateral prefrontal cortex (L DLPFC) on consecutive weekdays. Investigators will assess craving, substance use, and mood throughout the study and one-month post-treatment completion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Transcranial Magnetic Stimulation to Reduce Craving for Individuals With Opioid Use Disorder Taking Buprenorphine
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Drug Craving, as measured by 0-100 Visual Analog Scale [ Time Frame: End of TMS Treatments (2 weeks) ]
    Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)


Secondary Outcome Measures :
  1. Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use) [ Time Frame: End of TMS Treatments (2 weeks) ]
    Timeline Followback calendar, which measures days of opioid use over the past 2 weeks

  2. Retention in Buprenorphine Treatment [ Time Frame: End of TMS Treatments (2 weeks) ]
    Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments

  3. Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) [ Time Frame: End of TMS Treatments (2 weeks) ]
    Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms

  4. Drug Craving, as measured by 0-100 Visual Analog Scale [ Time Frame: Four-weeks after completion of TMS treatments ]
    Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)

  5. Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use) [ Time Frame: Four-weeks after completion of TMS treatments ]
    Timeline Followback calendar, which measures days of opioid use over the past month

  6. Retention in Buprenorphine Treatment [ Time Frame: Four-weeks after completion of TMS treatments ]
    Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments

  7. Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) [ Time Frame: Four-weeks after completion of TMS treatments ]
    Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653169


Contacts
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Contact: Heather B Ward, MD 617-732-5056 hbward@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Heather B Ward, MD Brigham and Women's Hospital

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Responsible Party: Heather Burrell Ward, Resident Physician in Psychiatry, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03653169     History of Changes
Other Study ID Numbers: 100313439
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Heather Burrell Ward, Brigham and Women's Hospital:
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists