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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03653169
• Other study ID #: 100313439
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: June 2021

Study information

• Verified date: February 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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	End of TMS Treatments (1 week)
Secondary	Retention in Buprenorphine Treatment	Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments	End of TMS Treatments (1 week)
Secondary	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	End of TMS Treatments (1 week)
Secondary	Drug Craving, as measured by 0-100 Visual Analog Scale	Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving)	1-2 weeks after completion of TMS treatments
Secondary	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	1-2 weeks after completion of TMS treatments
Secondary	Retention in Buprenorphine Treatment	Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments	1-2 weeks after completion of TMS treatments
Secondary	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	1-2 weeks after completion of TMS treatments
Secondary	Neuropsychologic Testing Battery	Penn Computerized Neuropsychologic Battery	End of TMS treatment (1 week)
Secondary	Impulsivity	Barratt Impulsivity Scale	End of TMS treatment (1 week)