Clinical trial NCT03653169: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Transcranial Magnetic Stimulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cue-Induced Craving, as measured by 0-100 Visual Analog Scale
timeFrame: End of TMS Treatments (1 week)
measure: Drug Craving, as measured by 0-100 Visual Analog Scale
timeFrame: End of TMS Treatments (1 week)
Secondary outcomes:
measure: Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
timeFrame: End of TMS Treatments (1 week)
measure: Retention in Buprenorphine Treatment
timeFrame: End of TMS Treatments (1 week)
measure: Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
timeFrame: End of TMS Treatments (1 week)
measure: Drug Craving, as measured by 0-100 Visual Analog Scale
timeFrame: 1-2 weeks after completion of TMS treatments
measure: Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use)
timeFrame: 1-2 weeks after completion of TMS treatments
measure: Retention in Buprenorphine Treatment
timeFrame: 1-2 weeks after completion of TMS treatments
measure: Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)
timeFrame: 1-2 weeks after completion of TMS treatments
measure: Neuropsychologic Testing Battery
timeFrame: End of TMS treatment (1 week)
measure: Impulsivity
timeFrame: End of TMS treatment (1 week)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Heather B Ward, MD
role: PRINCIPAL_INVESTIGATOR
References: