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

NCT03653169 | Withdrawn FDA Device

• 1 other identifier: 100313439
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 (twice daily for 5 days). The investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment.

Conditions

Opioid-use Disorder

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• Cue-Induced Craving, as measured by 0-100 Visual Analog Scale

  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

  Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)

  End of TMS Treatments (1 week)

Secondary Outcomes (9)

• Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)

  End of TMS Treatments (1 week)

• Retention in Buprenorphine Treatment

  End of TMS Treatments (1 week)

• Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)

  End of TMS Treatments (1 week)

• Drug Craving, as measured by 0-100 Visual Analog Scale

  1-2 weeks after completion of TMS treatments

• Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)

  1-2 weeks after completion of TMS treatments

Study Arms (1)

Open-Label Active TMS

EXPERIMENTAL

All subjects will receive open-label treatment with active Transcranial Magnetic Stimulation (TMS)

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

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).

Open-Label Active TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Heather B Ward, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Psychiatry

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 31, 2018
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)