TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TMS Low-Dose, TMS High-Dose.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder, Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcranial Magnetic Stimulation (TMS) to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
Overview
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
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).
Interventions
- Device 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). - 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).
Primary outcome measures
- Engagement in Treatment As Usual activities [Time frame: 4 weeks]
- Engagement in Treatment As Usual Activities [Time frame: 4 weeks]
- Engagement in Treatment As Usual Activities [Time frame: 4 weeks]
- Engagement in Treatment As Usual Activities [Time frame: 4 weeks]
Secondary outcome measures (5)
- Delay Discounting [Time frame: 4 weeks]
- Go/No-Go Task [Time frame: 4 weeks]
- Balloon Analogue Risk Task [Time frame: 4 weeks]
- Barratt Impulsiveness Scale-11 [Time frame: 4 weeks]
- Sensation Seeking Scale [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Another Chance Drug & Alcohol Rehab Center of Portland — Portland
Publications
- 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 32512513
- 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 38273429
- 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 33426970
Identifiers
NCT: NCT07171359 · TMS4OUDAUD · RECOVERYWORKSNWTMS