Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning

Opioid use disorders (OUDs) are common among Veterans. Despite the availability of opioid
replacement therapies, many individuals continue to abuse opioids and relapse rates remain
high. Veterans are nearly twice as likely to die from accidental opioid overdose than the
general population. Approximately 60% of Veterans returning from the Middle East and more
than 50% of older Veterans in the VA health care system have chronic pain. Further,
post-traumatic stress disorder, a common comorbidity in the Veteran population, has been
shown to negatively impact early engagement and retention of individuals in OUD treatment. As
is the case with other substance use disorders, opioid craving is commonly described by
abstinent patients whether or not they are stabilized on buprenorphine. Subsequently, a
treatment that reduces pain and craving, while also improving early engagement and retention
in treatment, would improve recovery from opioid addiction. Repetitive Transcranial Magnetic
Stimulation (rTMS) is capable of non-invasively altering cortical function. rTMS is an
FDA-approved treatment for major depressive disorder. Preliminary evidence suggests that rTMS
can also reduce pain in chronic pain conditions and craving in substance use disorders.
Single sessions of rTMS produce small temporary effects, while multiple sessions of rTMS
result in larger, more durable effects. The investigators' group recently completed a
blinded, sham-controlled crossover trial in non-treatment seeking OUD participants. A single
session of rTMS reduced cue-induced craving and increased thermal pain thresholds. Given that
multiple sessions of rTMS produce larger and more durable treatment effects than single
sessions of rTMS, it follows that multiple treatment sessions applied to OUD patients may
result in a clinically relevant reduction in pain and cue-induced craving, which could
improve clinical and functional outcomes.

In this SPiRE pilot proposal, the investigators will perform a randomized, double-blind,
sham-controlled trial delivering an accelerated course of rTMS to a cohort of OUD Veterans
with chronic pain receiving treatment through the Ralph H. Johnson VA Medical Center
Substance Treatment and Recovery program. The goal of this proposal is to evaluate the
feasibility and acceptability of delivering rTMS to the dorsolateral pre-frontal cortex in
Veterans with OUD and chronic pain. The investigators will also preliminarily explore the
feasibility of evaluating potential outcome measurements in preparation for a larger trial,
including abstinence, treatment retention, community reintegration and functional outcomes,
pain, and opioid craving. Positive results from this pilot project will inform a future MERIT
application and have the potential to significantly improve treatment outcomes in this
difficult to treat Veteran population.

Inclusion Criteria:

- Participants must be able to provide informed consent and function at an intellectual
level sufficient to allow accurate completion of all assessment instruments.

- Participants must meet moderate to severe DSM-5 criteria for OUD. While individuals
may also meet criteria for use disorders of other substances (with the exception of
alcohol or benzodiazepines), they must identify opioids as their primary substance of
abuse.

- Participants must report chronic pain for at least the past three months and have a
Brief Pain Inventory score.

- Participants must be receiving treatment through the STAR program.

Exclusion Criteria:

- Participants who are pregnant.

- Participants with a history of/or current psychotic disorder.

- Participants with a history of dementia or other cognitive impairment.

- Participants with active suicidal ideation, or a suicide attempt within the past 90
days will be excluded.

- Participants with contraindications to receiving rTMS (including a history of
seizures, or any implanted metal above the neck).

- Those with unstable general medical conditions.

- Those who are currently using naltrexone or tramadol.

- Those with current alcohol or benzodiazepine use disorders due to increased risk of
seizure.