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

Mass General Brigham

Status

Withdrawn

Conditions

Opioid-use Disorder

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03653169

100313439

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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