TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD) (TMS4OUDAUD)

Washington State University

Status: Not yet enrolling

Conditions: Opioid Use Disorder; Alcohol Use Disorder

Treatments: Device: TMS Low-Dose; Device: TMS High-Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT07171359

RECOVERYWORKSNWTMS (Other Identifier)

TMS4OUDAUD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Treatment As Usual

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Device: TMS Low-Dose

9-Minute TMS

Active Comparator group

Description:

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).

Treatment:

Device: TMS High-Dose