Alcohol Use DisorderTMS4OUDAUDNCT07171359
TMS to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
A study testing TMS Low-Dose and TMS High-Dose in people with Alcohol Use Disorder and Opioid Use Disorder, run by Washington State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Opioid Use Disorder
- What is being tested?
- TMS Low-Dose and TMS High-Dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Another Chance Drug & Alcohol Rehab Center of Portland
Portland, Oregon, 97232
John Morgan, CADC II, QMHA, 503-995-3718, johnm@anotherchancerehab.com
Benjamin Schwartz, MD, 503-997-3543, bens@recoveryworksnw.com
About this study
Official title: Transcranial Magnetic Stimulation (TMS) to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
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.
Read the 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.
- 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).
- 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).
- 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
- Alcohol Use Disorder, Opioid Use Disorder
- Being tested
- TMS Low-Dose, TMS High-Dose
- Keywords
- Transcranial Magnetic Stimulation, Opioid Use Disorder, Alcohol Use Disorder, Intensive Outpatient Treatment, Theta Burst Stimulation
- Medical subject headings
- Alcoholism, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: TMS High-Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Engagement in Treatment As Usual Activities
Number of individual treatment sessions attended from baseline assessment to follow up.
Measured: 4 weeks
Engagement in Treatment As Usual Activities
Number of group treatment sessions attended from baseline assessment to follow up.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
Delay Discounting
On this computer task, participants complete 5 trials where they are asked to choose between an immediate or a delayed reward (e.g., $5 now or $10 in 3 weeks). In this version of the delay discounting task, the delay duration adjusts depending on participants' choice on the previous trial. If participants choose the immediate reward, the next trial will have a shorter duration for the delayed reward (e.g., $10 in 1 day); if participants choose the delayed reward, the next trial will have a longer duration for the delayed reward (e.g., $10 in 2 years). Performance on the delay discounting task is measured by calculating the discounting rate, or the rate at which the value of a reward decreases as a function of delay. Higher discounting rates indicate a preference for smaller immediate rewards over larger delayed rewards and is associated with higher impulsivity. (Koffarnus \& Bickel, 2014)
Measured: 4 weeks
Go/No-Go Task
On this computer task, participants are asked to respond to stimuli by either executing ("go" stimuli) or withholding a response ("no-go" stimuli). More "go" stimuli are presented than "no-go" stimuli to induce a prepotent response. Performance on the Go/No-Go task is measured by calculating the proportion of commission errors (i.e., false alarms, making a response to a "no-go" stimulus), omission errors (i.e., misses, failing to respond to a "go" stimulus), and the response times to "go" stimuli. Higher proportions of commission errors are indicative of an inability to inhibit a response, sometimes referred to as rapid-response impulsivity. (Donders, 1969)
Measured: 4 weeks
Balloon Analogue Risk Task
On this computer task, participants are shown a balloon and told that each press of a button will increase the size of the balloon and reward them with a small, hypothetical monetary reward. However, after a variable number of pumps, the balloon will explode, causing them to lose all accumulated rewards on that trial. Participants can pump up the balloon as much as they want before moving onto the next trial. Performance on the BART is measured by calculating the average number of pumps on each balloon excluding balloons that exploded. A higher average number of pumps is associated with more impulsiveness. (BART; Lejuez et al., 2002)
Measured: 4 weeks
Barratt Impulsiveness Scale-11
On this 30-item questionnaire, participants use a 4-point Likert-type scale (1 = Rarely/Never, 4 = Almost Always/Always) to indicate how frequently statements like "I do things without thinking" and "I concentrate easily" apply to themselves. The BIS-11 total score is a summed score of all responses and can range from 30 to 120, with higher scores indicating higher levels of impulsiveness. There is also an option to calculate scores for three aspects of impulsiveness: attentional, motor, and nonplanning. These subscale scores are calculated by summing the number of associated items. The attentional impulsiveness subscale consists of 8 items, and total scores can range from 8 to 32; the other two subscale scores are 11 items each and scores can range from 11 to 44. (BIS-11; Patton et al., 1995)
Measured: 4 weeks
Sensation Seeking Scale
On this 40-item questionnaire, participants are shown two choices, like "A. I prefer friends who are excitingly unpredictable or B. I prefer friends who are reliable and predictable," and asked to select the statement that most or best describes how they feel. One point is given for the more sensation-seeking choice. The SSS total score is the sum of all more sensation-seeking choices and can range from 0 to 40, with higher scores indicating more sensation-seeking. There is also an option to calculate scores for each of the four factors that make up sensation-seeking: [social and sexual] disinhibition, boredom susceptibility, thrill and adventure seeking, and experience seeking. Each of these scales is made up of 10 of the items and scores can range from 0 to 10. (SSS; Zuckerman et al., 1964)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Jun 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew E Layton, MD, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171359
- Sponsor's protocol ID
- TMS4OUDAUD
- Other IDs
- RECOVERYWORKSNWTMS
- Acronym
- TMS4OUDAUD
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
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.
PubMed 32512513Bormann 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.
PubMed 38273429Tsai 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.
PubMed 33426970
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) to Improve Recovery Outcomes Among Patients With Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT07171359
- Acronym / sponsor ID
- TMS4OUDAUD / TMS4OUDAUD
- Conditions
- Alcohol Use Disorder, Opioid Use Disorder
- Keywords
- Transcranial Magnetic Stimulation, Opioid Use Disorder, Alcohol Use Disorder, Intensive Outpatient Treatment, Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- 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).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: TMS Low-DoseTAU + 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). |
| 9-Minute TMS | Active comparator | Device: TMS High-DoseTAU + 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Children <18 years old
- Pregnant
- Non-English speaking
- Currently taking prescription benzodiazepines or anti-convulsive medications
- In active alcohol or opioid withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS Low-Doseone 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 | 3-Minute TMS |
| TMS High-DoseOne 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 | 9-Minute TMS |
Primary outcome
Engagement in Treatment As Usual activities
Time frame: 4 weeks
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.
Engagement in Treatment As Usual Activities
Time frame: 4 weeks
Number of individual treatment sessions attended from baseline assessment to follow up.
Engagement in Treatment As Usual Activities
Time frame: 4 weeks
Number of group treatment sessions attended from baseline assessment to follow up.
Engagement in Treatment As Usual Activities
Time frame: 4 weeks
Number of negative urine toxicology screens for illicit drugs or unprescribed medications from baseline assessment to follow up.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 32512513Liu 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.
- Background: PubMed 38273429Bormann 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.
- Background: PubMed 33426970Tsai 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew E Layton, MD, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS Low-Dose and TMS High-Dose in people with Alcohol Use Disorder and Opioid Use Disorder, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew E Layton, MD, PhD (509-389-1108, layton@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Treatment As Usual activities (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171359, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.