100 Participants NeededMy employer runs this trial

Transcranial Magnetic Stimulation for Opiate Dependence

(VICTORY Trial)

Recruiting at 1 trial location
JG
Overseen ByJillian G Connolly, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether stimulating a specific brain area with repetitive Transcranial Magnetic Stimulation (rTMS) can reduce cravings and opioid use in individuals with opiate dependence. Participants will undergo brain stimulation sessions, and some may opt for brain imaging to observe its effects on the brain. Ideal candidates are those who began taking buprenorphine for opioid use disorder within the past year and have experienced a return to opioid use during that period. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for opioid dependence.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, a doctor will review your medications to decide if you can participate, considering your medical history and any recent changes in your medication.

What prior data suggests that transcranial magnetic stimulation is safe for opiate dependence?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and easy to manage. In previous studies, most participants experienced only minor side effects, such as a mild headache or slight pain during or after treatment. These symptoms typically resolve on their own or can be managed with over-the-counter pain medication.

When applied to opioid dependence, rTMS has shown promise in reducing cravings. The physical risks remain low, and safety measures, such as wearing earplugs during the procedure, help prevent potential side effects like hearing loss. Overall, while more research is needed, current evidence suggests that rTMS is a safe option for many individuals.12345

Why are researchers excited about this trial?

Most treatments for opiate dependence, like methadone or buprenorphine, work by replacing or reducing opioid use through chemical means. But Repetitive Transcranial Magnetic Stimulation (rTMS) works differently, targeting brain activity with magnetic pulses. This technique is non-invasive and drug-free, focusing on stimulating specific parts of the brain, potentially reducing cravings and withdrawal symptoms. Researchers are excited because rTMS offers a new avenue that might help those who haven't had success with traditional medication therapies. Plus, it could lead to fewer side effects compared to current drug-based treatments.

What evidence suggests that transcranial magnetic stimulation is effective for opiate dependence?

Research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) can help reduce cravings for opioids. In this trial, participants will receive either active rTMS or a sham treatment. One study demonstrated that a session of rTMS targeting a brain area involved in decision-making decreased these cravings. Additional research suggests that rTMS might benefit people with opioid use disorder by reducing cravings triggered by specific cues. These findings indicate that rTMS could be a promising tool for managing opioid dependence by influencing brain areas related to cravings.35678

Who Is on the Research Team?

HW

Heather Ward, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have opioid use disorder, are in stable outpatient psychiatric care, started buprenorphine within the past year, and have used opioids again during that time. Participants must be able to understand English and complete study procedures.

Inclusion Criteria

I am in stable outpatient psychiatric care and my mental health is stable.
I am between 18 and 65 years old.
* Diagnosis of OUD according to DSM-5 criteria and confirmed by SCID
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (phone or in-person)

Consent and Initial Assessment

Participants complete informed consent and undergo additional screening procedures, including questionnaires about substance use and psychiatric symptoms.

1 week
1 visit (in-person)

Treatment

Participants receive 8 weekly sessions of L DLPFC-targeted iTBS or sham iTBS. Each session includes 2 iTBS treatments separated by a 50-minute break.

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits at weeks 10, 12, and 20 to complete questionnaires and provide urine samples.

12 weeks
3 visits (in-person or virtual)

Optional Open-label Extension

Participants who received sham iTBS are offered 8 weekly sessions of open-label active iTBS.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive device that stimulates specific brain areas, to see if it affects cravings and opioid use. Some participants may also get optional MRI scans. The study involves about 12 visits over five months.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: L DLPFC-Targeted iTBSActive Control1 Intervention
Group II: L DLPFC-Targeted Sham TMSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

A Case Report Illustrating the Effects of Repetitive ... - PMC

The one published study on the use of repetitive TMS (rTMS) for OUD found that a single session of rTMS to the left DLPFC reduced cue-induced craving in long- ...

The effects of repetitive transcranial magnetic stimulation ...

Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder ( ...

An Open-Label Trial of Repetitive Transcranial Magnetic ...

The purpose of this study is to understand the role of repetitive Transcranial Magnetic Stimulation (rTMS) in reducing opioid and other substance use and ...

A narrative review | Journal of Opioid Management

TMS has been seen in some studies to significantly reduce cravings for opioids with effects beyond the last administrated treatment.

Deep Transcranial Magnetic Stimulation in Patients ... - PMC

This randomized controlled trial evaluated the efficacy of accelerated wide‐volume deep TMS using a double‐cone coil in patients with opioid use disorder.

Effectiveness and safety of repetitive transcranial magnetic ...

The findings of this study showed that rTMS treatment showed promising effectiveness on patients with MD. However, future studies should focus on warranting the ...

the Role of Repetitive Trans Cranial-magnetic Stimulation ...

Age range: 18-45 years old · Gender: males · Opioid Use disorder according to the DSM-5 (early abstinence starting 1 week up to 1 month).

Repetitive transcranial magnetic stimulation for the treatment ...

Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder: A pilot feasibility randomized controlled ...