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

Primary Purpose

Opioid-use Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham & Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Active TMS

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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

Timeline Followback calendar, which measures days of opioid use over the past 2 weeks

Retention in Buprenorphine Treatment

Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments

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

Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms

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

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

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

Timeline Followback calendar, which measures days of opioid use over the past month

Retention in Buprenorphine Treatment

Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments

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

Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms

Neuropsychologic Testing Battery

Penn Computerized Neuropsychologic Battery

Impulsivity

Barratt Impulsivity Scale

Full Information

NCT ID

NCT03653169

First Posted

August 27, 2018

Last Updated

February 28, 2022

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03653169

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Investigator left institution

Study Start Date

January 2021 (Anticipated)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

Keywords

Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open-Label Active TMS

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Transcranial Magnetic Stimulation

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

End of TMS Treatments (1 week)

Title

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

Description

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

Time Frame

End of TMS Treatments (1 week)

Secondary Outcome Measure Information:

Title

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

Description

Timeline Followback calendar, which measures days of opioid use over the past 2 weeks

Time Frame

End of TMS Treatments (1 week)

Title

Retention in Buprenorphine Treatment

Description

Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments

Time Frame

End of TMS Treatments (1 week)

Title

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

Description

Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms

Time Frame

End of TMS Treatments (1 week)

Title

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

Description

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

Time Frame

1-2 weeks after completion of TMS treatments

Title

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

Description

Timeline Followback calendar, which measures days of opioid use over the past month

Time Frame

1-2 weeks after completion of TMS treatments

Title

Retention in Buprenorphine Treatment

Description

Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments

Time Frame

1-2 weeks after completion of TMS treatments

Title

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

Description

Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms

Time Frame

1-2 weeks after completion of TMS treatments

Title

Neuropsychologic Testing Battery

Description

Penn Computerized Neuropsychologic Battery

Time Frame

End of TMS treatment (1 week)

Title

Impulsivity

Description

Barratt Impulsivity Scale

Time Frame

End of TMS treatment (1 week)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather B Ward, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham & Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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