TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)

NCT ID: NCT07171359

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-09-30

Brief Summary

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The study aims to explore the potential of Transcranial Magnetic Stimulation (TMS), particularly Theta Burst Stimulation (TBS), as an adjunctive treatment to enhance recovery outcomes (consumption and craving; withdrawal symptoms; mental, physical, sleep, and cognitive health; engagement with therapy, etc.) in individuals with Opioid Use Disorder (OUD) and individuals with Alcohol Use Disorder (AUD). This project will be completed in partnership with Another Chance Rehab (Portland): Portland's top addiction treatment program offering evidence-based treatment programs for a range of substance use disorders. Another Chance Rehab will serve as the project site for this work.

Detailed Description

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The investigators will conduct a prospective, randomized, controlled trial. To identify which TMS protocol is most efficacious, there will be three arms to this study.

1. Treatment as Usual (TAU): Participants complete their regularly scheduled therapy activities and receive no add-on TMS. They will answer the demographic survey and outcome measure surveys (listed in a later section).
2. TAU + 3-minute TMS: Participants complete TAU as described above, with one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).
3. TAU + 9-minute TMS: Participants complete TAU as described above, with one 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Conditions

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Alcohol Use Disorder Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment As Usual (TAU) for OUD and AUD vs. TAU+TMS 3 minute Theta Burst Stimulation (TBS) vs. TAU+TMS 9 minute TBS, 20 sessions for each individual in the intervention arms over 4 weeks
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment As Usual

Study participants in this arm will engage in intensive outpatient alcohol and addiction treatment provided as it usually is for all patients in this program.

Group Type NO_INTERVENTION

No interventions assigned to this group

3-Minute TMS

TAU + 3-minute TMS: Participants complete TAU as described above, with one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Group Type ACTIVE_COMPARATOR

TMS Low-Dose

Intervention Type DEVICE

one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

9-Minute TMS

TAU + 9-minute TMS: Participants complete TAU as described above, with one 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Group Type ACTIVE_COMPARATOR

TMS High-Dose

Intervention Type DEVICE

One 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Interventions

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TMS Low-Dose

one 3-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Intervention Type DEVICE

TMS High-Dose

One 9-minute session of TMS TBS delivered each morning, prior to commencement of their regularly scheduled daily therapy activities, for 5 days/week, for a total of four-weeks (20 sessions total).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18+ years old
* Enrolled in the Intensive Outpatient Program at Another Chance Drug \& Alcohol Rehab Center of Portland, Portland, OR.
* Diagnosed with Opioid Use Disorder
* Diagnosed with Alcohol Use Disorder

Exclusion Criteria

* Children \<18 years old
* Pregnant
* Non-English speaking
* Currently taking prescription benzodiazepines or anti-convulsive medications
* In active alcohol or opioid withdrawal
* History of seizure disorder diagnosis
* History of Schizophrenia, Bipolar Disorder, Mania
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew E Layton, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

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Another Chance Drug & Alcohol Rehab Center of Portland

Portland, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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Matthew E Layton, MD, PhD

Role: CONTACT

509-389-1108

Poppy M Gardiner, PhD

Role: CONTACT

509-428-4236

Facility Contacts

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John Morgan, CADC II, QMHA

Role: primary

503-995-3718

Benjamin Schwartz, MD

Role: backup

503-997-3543

References

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Liu X, Zhao X, Liu T, Liu Q, Tang L, Zhang H, Luo W, Daskalakis ZJ, Yuan TF. The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder. EBioMedicine. 2020 Jun;56:102809. doi: 10.1016/j.ebiom.2020.102809. Epub 2020 Jun 5.

Reference Type BACKGROUND
PMID: 32512513 (View on PubMed)

Bormann NL, Oesterle TS, Arndt S, Karpyak VM, Croarkin PE. Systematic review and meta-analysis: Combining transcranial magnetic stimulation or direct current stimulation with pharmacotherapy for treatment of substance use disorders. Am J Addict. 2024 May;33(3):269-282. doi: 10.1111/ajad.13517. Epub 2024 Jan 25.

Reference Type BACKGROUND
PMID: 38273429 (View on PubMed)

Tsai TY, Wang TY, Liu YC, Lee PW, Chang WH, Lu TH, Tseng HH, Lee SY, Chang YH, Yang Y, Chen PS, Chen KC, Yang YK, Lu RB. Add-on repetitive transcranial magnetic stimulation in patients with opioid use disorder undergoing methadone maintenance therapy. Am J Drug Alcohol Abuse. 2021 May 4;47(3):330-343. doi: 10.1080/00952990.2020.1849247. Epub 2021 Jan 10.

Reference Type BACKGROUND
PMID: 33426970 (View on PubMed)

Other Identifiers

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RECOVERYWORKSNWTMS

Identifier Type: OTHER

Identifier Source: secondary_id

TMS4OUDAUD

Identifier Type: -

Identifier Source: org_study_id

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