Introduction
Top of page 1 — welcome and study overview
What this is: The study title and who is running it. Dr. Layton at WSU is the lead. His contact info is right on the form.
"This section welcomes you. Before you decide to join, we want you to fully understand what's involved — that's what this whole form is for."
Key Information
The big-picture overview — seven bullet points
What this covers: The most important facts all in one place.
- Voluntary. You are choosing to join. No one is making you.
- What we're testing. Whether TMS (a type of brain stimulation) helps people in recovery from opioid or alcohol use. Partnership with Another Chance.
- Three groups — random assignment. ① Regular treatment only. ② Regular treatment + 3 min TMS each morning for 20 sessions (4 weeks). ③ Regular treatment + 9 min TMS each morning for 20 sessions. Everyone answers surveys about cravings, withdrawal, health, sleep, memory, and thinking.
- Risks are small. Most common: mild headache or sore scalp. These go away. TMS has never caused a death. Settings are well within safety limits.
- No promises. We can't guarantee TMS will help you. It's still experimental. But what we learn may help people in the future.
- No other procedures. Nothing beyond what's described here.
- Research only — not treatment. If you get TMS, it's extra — on top of your regular treatment.
Purpose of the Study
Bottom of page 1
What this covers: Why we're doing this research.
"We want to find out if TMS — added to regular treatment — helps people with opioid or alcohol use disorder. Your participation helps us answer that question."
Benefits
Top of page 2
What this covers: What you might get out of joining.
"There may be no direct benefit to you personally. But by joining, you're helping us learn things that could help other people in recovery down the road."
Eligibility
Who can and cannot join — checklist format
What this covers: The list of requirements. We already screened for most of this.
You must:
- Be 18–65 years old
- Have OUD or AUD diagnosis
- Be enrolled in treatment at Another Chance
- Read and communicate in English
You cannot:
- Be pregnant or nursing
- Be on benzodiazepines or test positive for them or street drugs (3 positives = removal)
- Have bipolar disorder, psychosis, seizures, epilepsy, stroke, or serious head injury
- Have certain heart conditions
- Have metal implants in head or body (pacemaker, aneurysm clips, cochlear implant, etc.)
- Be on anti-seizure meds or stimulants
- Have noise-induced hearing loss or tinnitus that would be a problem
- Be scheduled for discharge before all 20 sessions can be completed
Step 1 — Sign Up & Consent
First visit — overview, screening, consent
What this covers: What happens right now.
"Step 1 is what we're doing right now. You get an overview, we do a quick screening, then we go through this consent form together. You can ask any questions. Once you're ready, you sign."
⚠ Pregnancy test: Women who could become pregnant give a urine sample now and before each TMS session.
Step 2 — Baseline Measures
Surveys and tests before anything starts (~45 min)
What this covers: The surveys you fill out before beginning.
"Before any TMS, we'll ask background questions and have you fill out surveys about withdrawal symptoms, drug and alcohol use, cravings, mental health, sleep, and thinking skills. Takes about 45 minutes. We'll also have permission to look at your treatment records from Another Chance."
After surveys, a computer randomly assigns you to one of the three groups.
Step 3 — TMS Procedure
What happens during TMS sessions (TMS groups only)
What this covers: Each day's TMS routine.
- Weekday mornings for 20 days (4 weeks)
- Urine sample before each session — positive = no TMS that day
- Fitted for a head cap that helps position the coil
- Sit in a chair, receive TMS (3 or 9 min) via Theta Burst Stimulation
- Coil placed on side of head, targeting a brain region linked to addiction
- After the session, back to regular treatment activities
Step 4 — TAU Procedure
What happens if you're in the no-TMS group
What this covers: The treatment-as-usual-only path.
"If you're in the no-TMS group, you won't get TMS. But you'll still do all the same surveys at the same times as the TMS groups — six total times. Your participation is still very important because your results help us compare."
Step 5 — Outcome Measures
Follow-up surveys — everyone does these
What this covers: The repeated surveys over time.
"At the end of each week — four times during treatment, plus one more time a week after treatment ends — you'll repeat the same surveys. We'll also check your Another Chance records again. All answers are recorded on a tablet, password-protected. Everyone does these follow-ups the same way, no matter which group you're in."
Length of Participation
How long the whole thing takes
What this covers: The time commitment.
"About six weeks total: Week 1 — sign up and first surveys. Weeks 2–5 — daily TMS (or regular treatment) and weekly surveys. Week 6 — one last round of surveys. Surveys take 30–45 minutes. TMS sessions take 10–15 minutes."
Compensation & Costs
Payment, travel costs, and what happens if something goes wrong
What this covers: Money and expenses.
"If you finish the study, you can get up to $100 in gift cards. There might be travel costs if you need to arrive earlier than usual. If something goes wrong because of the study, we don't offer money or free medical care for it. Contact Dr. Layton right away if you have any problems."
Confidentiality
How your personal information is protected
What this covers: Privacy protections.
"Your privacy is taken seriously. Your data is stored without your name — we use codes like TAU01 or 3min01. A master list connects your name to your code, kept in a separate password-protected file. Only the research team who need to know can access it. Paper forms are locked at Another Chance, then moved to WSU. Your Another Chance records are shared through secure, password-protected file sharing. Drug screen results before each TMS session are shared with you."
Risks
What could go wrong
What this covers: Side effects.
"TMS side effects are minor and temporary — usually just a mild headache or some scalp discomfort. TMS has never caused a death. The settings we're using are well within safety limits. The risks are low."
Voluntary Participation
Your right to say no or quit at any time
What this covers: Your rights to choose and to leave.
"Joining is completely your choice. You can say no with no penalty. You can skip questions you don't want to answer. You can change your mind and leave at any time — no consequences, no loss of benefits. If we learn new information that might change how you feel, we'll tell you. If you leave, Dr. Layton will talk with you about whether we can still use the data we already collected."
SAMHSA Records Release (42 CFR 2.31)
Permission to look at your treatment records
What this covers: Access to your Another Chance records under federal privacy law.
"Federal law protects your substance use treatment records. This form gives us permission to look at them during the study — things like your prescribed medications and drug screen results. You can withdraw this permission at any time. Only the research team sees these records, and only while you're in the study and for 90 days after. We can't share this information with anyone else without your written permission."
Funding & Conflict of Interest
Who paid for the study and any conflicts
What this covers: Transparency about funding.
"Dr. Ben Schwartz provided the funding and the TMS machine through his nonprofit, RecoveryWorksNW. He is also a co-investigator. If the results are positive, he could benefit financially. To keep things fair, Dr. Schwartz and anyone paid by his nonprofit are not involved in the consent process — they won't be the ones explaining the study or getting your signature."
Questions & Contacts
Who to call with questions
What this covers: Contact information.
"If you have questions about the study, contact Dr. Layton directly — his phone and email are right here. The WSU Institutional Review Board — the group that approved this study to make sure it's ethical — can also be contacted if you have concerns about your rights: irb@wsu.edu."
Signature Section
Where the participant signs — bottom of page 5
What this covers: The actual signature.
"This is where you sign. There are two checkboxes: one says you've read and understood the form, had your questions answered, and you're choosing to join. The other says you do not consent. You'll get a copy of this signed form for your own records."
Signatures & LAR
SAMHSA checkbox, signatures, and Legally Authorized Representative
What this covers: Page 6 — final signatures.
"Page 6 has one more checkbox — specifically allowing us to access your Another Chance records under the federal privacy law we discussed. Then there are signature lines for you, the researcher, and a witness."
LAR section (bottom of page): Only used if the participant can't sign for themselves — for example, if someone has a legal guardian. If that doesn't apply, skip this part. It allows a legally authorized person to sign on the participant's behalf.