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TMS for Opioid Use Disorder

N/A

Waitlist Available

Led By Kathryn C Biernacki, Ph.D.

Research Sponsored by National Institute on Drug Abuse (NIDA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must meet DSM-5 criteria for an opioid use disorder (active or in remission and on maintenance therapy)

Participants will be volunteers between the ages of 18-60

Must not have

Participants must not consume cannabis more than once per week and must not exceed more than 1g of cannabis or 50mg THC per week

Subjects with suicidal ideation where outpatient treatment is determined unsafe

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-3 months

Summary

"This trial aims to study how a type of brain stimulation called transcranial magnetic stimulation (TMS) can help individuals who use opioids like heroin or methadone. TMS uses magnetic pulses to

Who is the study for?

This trial is for people aged 18 to 60 who either have an opioid use disorder (OUD) or are healthy volunteers. Participants with OUD may be using opioids like heroin or methadone. All participants must pass a screening and be able to safely receive TMS, which will be determined by the study team.

What is being tested?

The study tests how transcranial magnetic stimulation (TMS), a brain stimulation technique, affects decision-making in those with and without OUD. It involves MRI scans while doing computer tasks and two sessions of both real and placebo TMS over one to three months.

What are the potential side effects?

TMS can cause discomfort at the site on the head where it's applied, headaches, lightheadedness, or seizures in rare cases. The sham TMS mimics real TMS but doesn't stimulate the brain; side effects should be minimal if any.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an opioid addiction, either active or in remission.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use cannabis no more than once a week and under 1g or 50mg THC.

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I have thoughts of harming myself and need more than outpatient care.

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I have never had a major head injury that affected my brain function.

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I cannot speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine neural correlates of risk and ambiguity tolerance in healthy controls and people with OUD.

Measure the impact of transcranial magnetic stimulation (TMS) on ambiguity tolerance in healthy controls and people with OUD

Secondary study objectives

Determine the impact TMS on outcomes that are relevant to substance use and relapse (e.g., craving)

Determine the impact of TMS on resting-state brain activity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TMSActive Control1 Intervention

Participants will be blinded as to which sessions involve active TMS or sham. Those study staff involved in interacting with the participant will also be blinded. Participants will be randomized into either active-sham or sham-active session order.

Group II: Sham TMSPlacebo Group1 Intervention

0 / 6Eligibility criteria met