NCT07171359

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

August 26, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

August 26, 2025

Last Update Submit

September 5, 2025

Conditions

Alcohol Use DisorderOpioid Use Disorder

Keywords

Transcranial Magnetic StimulationOpioid Use DisorderAlcohol Use DisorderIntensive Outpatient TreatmentTheta Burst Stimulation

Outcome Measures

Primary Outcomes (4)

  • Engagement in Treatment As Usual activities

    The Investigators will compare engagement in treatment as usual within and between groups by Number of Days in attendance from baseline assessment to follow up.

    4 weeks

  • Engagement in Treatment As Usual Activities

    Number of individual treatment sessions attended from baseline assessment to follow up.

    4 weeks

  • Engagement in Treatment As Usual Activities

    Number of group treatment sessions attended from baseline assessment to follow up.

    4 weeks

  • Engagement in Treatment As Usual Activities

    Number of negative urine toxicology screens for illicit drugs or unprescribed medications from baseline assessment to follow up.

    4 weeks

Secondary Outcomes (5)

  • Delay Discounting

    4 weeks

  • Go/No-Go Task

    4 weeks

  • Balloon Analogue Risk Task

    4 weeks

  • Barratt Impulsiveness Scale-11

    4 weeks

  • Sensation Seeking Scale

    4 weeks

Study Arms (3)

Treatment As Usual

NO INTERVENTION

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.

3-Minute TMS

ACTIVE COMPARATOR

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).

Device: TMS Low-Dose

9-Minute TMS

ACTIVE COMPARATOR

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).

Device: TMS High-Dose

Interventions

TMS Low-DoseDEVICE

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-Minute TMS
TMS High-DoseDEVICE

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).

9-Minute TMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Another Chance Drug & Alcohol Rehab Center of Portland

Portland, Oregon, 97232, United States

Location

Related Publications (3)

  • 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.

    PMID: 32512513BACKGROUND

  • 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.

    PMID: 38273429BACKGROUND

  • 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.

    PMID: 33426970BACKGROUND

MeSH Terms

Conditions

AlcoholismOpioid-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Matthew E Layton, MD, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew E Layton, MD, PhD

CONTACT

509-389-1108layton@wsu.edu

Poppy M Gardiner, PhD

CONTACT

509-428-4236poppymay.gardiner@wsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 12, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The investigators plan to implement a Data Use and Sharing Agreement between WSU and Another Chance Rehab Center for internal use and collaboration among study team members only. Data collected for this study will be de-identified prior to analysis and dissemination of results, therefore no IPD will be shared with other researchers.

Locations

US(1)