SODA — Stability of Opioid Dose Assessment

Regulatory Position

What SODA is — and what it is not

SODA is positioned as a patient-mediated reflection and communication tool. A formal regulatory classification enquiry was submitted to the MHRA Innovation Office in March 2026. DCB0129/0160 clinical safety framework is in place.

✓ What SODA is

✅

A structured reflection tool for people in opioid treatment

✅

Captures patient-reported experience: withdrawal, craving, use, adherence

✅

Generates a consistent, repeatable summary of patient-reported treatment experience

✅

Supports shared decision-making conversations between patients and clinicians

✅

Works across community, GP shared care, pharmacy, and prison settings

✅

No integration required · fits within existing appointments

✕ What SODA is not

❌

Not a clinical decision support tool

❌

Does not provide dosing advice or recommend dose changes

❌

Does not diagnose, treat, or make clinical recommendations

❌

Does not trigger automated clinical actions

❌

Does not generate predictive models or apply clinical algorithms

❌

Does not provide emergency or acute care guidance

SODA summarises self-reported treatment experience to support reflection and discussion during care. It does not provide medical advice, recommend treatment or dose changes, or determine urgency of clinical review. Clinical decisions remain the responsibility of the prescriber.

Understanding Stability

Stable vs not stable in treatment

SODA helps make treatment stability visible and discussable. Whether someone describes themselves as stable or not stable is based on their own reported experience — not a clinical determination.

✓

Stable

😊

No withdrawal between doses

🧠

Not thinking about using

🙌

Not using on top

📅

Not missing doses

How people often describe this pattern

You describe your treatment as working well at the moment — feeling settled and in control of your day.

Not Stable

😔

Withdrawal between doses

🧠

Thinking about using

💉

Using on top

📅

Missing doses

How people often describe this pattern

You describe ongoing difficulties with your treatment experience. It may be worth discussing how things are going with your keyworker or prescriber.

Lots of things affect how you feel — but your medication is one part that can be explored and improved together.

The Problem SODA Solves

Despite decades of evidence, there is no simple point-of-care way to structure how people describe whether their opioid medication feels adequate day to day.

Existing monitoring systems — NDTMS, TOP, MAPS — are retrospective and population-level. They do not support real-time conversation within a consultation. As a result, instability in treatment experience may not be consistently explored within routine care.

📊

Existing tools record outcomes

TOPS, NDTMS, MAPS, and similar instruments capture what happens after care. They are valuable for population monitoring but are not designed to inform conversations within a consultation. They do not tell a clinician whether a patient sitting in front of them today is experiencing withdrawal, craving or ongoing opioid use between doses.

🔇

Instability is largely invisible

Fewer than half of 140,000 people on OST in England are making meaningful progress (NDTMS). Many are retained in treatment but not stable — experiencing ongoing withdrawal, persistent craving, or regular on-top use that goes unrecognised and unaddressed between reviews.

⚡

The cost of missing instability

When instability in treatment experience goes unrecognised and unaddressed, the opportunity to improve things is missed. Patients disengage. Overdose risk rises — particularly at high-risk transitions like release from prison. Opioid-related deaths in the UK have more than doubled since 2012, with around 5,000 each year.

What existing tools do

Record patient status for reporting purposes

Track broad outcomes such as retention and drug use

Generate population-level data for commissioners

Measure what happens after treatment decisions — not before

What they don't do

Structure the medication conversation in the room

Make instability in treatment experience visible in real time

Offer a common language for patients and clinical staff

Enable non-prescribers to recognise and raise concerns about instability

What SODA adds

A 5-minute patient-completed assessment embedded within the consultation

A structured summary of withdrawal, craving, adherence and on-top use, available in real time

A shared language that patients and clinicians can use together

A consistent, repeatable summary that supports structured discussion about treatment experience

Helps non-prescribing keyworkers recognise and raise concerns about instability

Works across community, GP shared care, pharmacy, and prison settings without integration

"SODA gives shared meaning and language by structuring a conversation that was previously informal, inconsistent, and often simply not happening."

For People in Treatment

Understanding how well your treatment is working for you

SODA is a way of describing how your treatment feels for you. It asks simple questions about things like withdrawal, craving and whether you are using on top of your medication. There are no right or wrong answers — it is simply a way of putting your experience into words, so it is easier to discuss with your care team.

You choose whether to share the result with your keyworker or prescriber. SODA does not make any decisions — that stays entirely with your clinical team. You can use it once, or come back to it over time to see how things change.

Works for methadone, oral buprenorphine, weekly and monthly depot injections

Audio option available — bypasses health literacy barriers

Anonymous by default — no personal data required

Optional account to track your own progress across services and medications over time

Available in community services, GP shared care, pharmacies, and prisons

Try SODA v1 at mydose.digital →

SODA is a reflection and conversation tool. It does not provide medical advice, recommend dose changes, or replace clinical assessment. All medication decisions must be made by your prescriber. If you feel very unwell or at risk of overdose, seek urgent medical help immediately.

SODA Stability Bands

😌

0–3 · Stable

You describe your treatment as working well at the moment.

😐

4–8 · Mostly Stable

You describe your treatment as mostly working, with some gaps that could be discussed with your care team.

😟

9–13 · Moderate Instability

You describe some ongoing difficulties with your treatment experience. This may be something to discuss with your prescriber.

😔

14–20 · High Instability

You describe significant difficulties with your treatment experience. It is worth discussing how things are going with your prescriber.

Scoring across three domains — 0 to 20

Withdrawal experience (0–10) · Craving and on-top use (0–8) · Adherence (0–2). Higher scores indicate greater instability in day-to-day treatment experience.

Harm Reduction

🟥 Naloxone — know where yours is

SODA includes naloxone information because recognising when treatment is not working well is only part of the picture — people also need simple, accessible ways to reduce immediate risk. Overdose risk increases during periods of instability, missed doses, dose reduction, and particularly following release from prison.

SODA helps people see risk — not tells them what to do.

🟥 Naloxone saves lives — Emergency overdose reversal ▾

Naloxone can temporarily reverse an opioid overdose.

Call emergency services immediately
Give naloxone — even if unsure whether it is an overdose
Stay with the person
Repeat doses if needed — effects can wear off before the opioid does

Naloxone wears off in 30–90 minutes — medical attention is still needed even if the person seems to recover. Ask your service about a free kit and training.

Why it matters on OST

Using on top of your OST — especially when treatment isn't fully covering you — raises overdose risk
Missing doses lowers your tolerance; your usual amount can have a stronger effect than expected
At key transition points your tolerance may be lower than you realise

🔓 Prison release 💊 Changing medication ⬇️ Reducing dose

What to do

Ask your keyworker or prescriber for a take-home naloxone kit at your next appointment
Keep it somewhere easy to find quickly — and tell at least one person where it is
Show someone you trust how to use it. Nasal spray naloxone is simple and requires no medical training
Check the expiry date occasionally — your service will replace it for free

Naloxone does not replace calling 999. If someone is unresponsive and you suspect overdose: call 999 first, give naloxone while you wait, put them in the recovery position. Naloxone wears off in 30–90 minutes — the person needs medical attention even if they seem to recover.

Find naloxone near me →

Free from most pharmacies, drug services, and GP practices.
No prescription needed to carry it.

Naloxone is a safety tool and does not replace medical care.

How It Works

How SODA works in a consultation

SODA helps make aspects of treatment experience visible and easier to discuss within the consultation. It is simpler than what services currently do.

📱

Patient Completes SODA

5 minutes on any device

📋

Structured Summary

Withdrawal, craving, adherence, use

🎯

Stability Score & Band

0–20 across four bands

⚠️

Experience Visible

Patient and clinician can see patterns together

💬

Shared Discussion

Structured conversation begins

🩺

Conversation Continues

Any next steps decided by clinician and patient together

SODA provides a structured summary of treatment experience to support reflection and discussion between patients and their care team.
It does not provide recommendations, suggest dose changes, or determine clinical action. All clinical judgement remains with the treating clinician.

Pilot Evidence

What the pilot data shows

SODA v1 was piloted with over 1,000 patients across three community drug services in England. Results demonstrate high acceptability, face validity, and a consistent and interpretable summary of treatment experience that is usable at scale.

80%+

Rated SODA accurate

Over 80% of patients reported that SODA accurately reflected their treatment experience (combining "totally" and "somewhat" accurate responses). Perceived accuracy was highest among those with greatest instability (81.5% in Band 4).

61%

In moderate–high instability bands

61% of the community OST sample scored in moderate-to-high instability (SODA 9–20) — a pattern of treatment experience that would otherwise be largely invisible without structured measurement.

37%

Repeat completion rate

37% of participants completed SODA more than once under conditions of minimal implementation support — with no prompting, workflow integration, or follow-up mechanisms in place. The v2 programme is specifically designed to address this through structured SPRINT-model adoption support across all sites.

Intention to Discuss Treatment by Stability Band

Pilot data · n > 800 community OST patients · % intending to discuss treatment with prescriber after completing SODA

60%

0–3
Stable

70%

4–8
Mostly Stable

82%

9–13
Moderate Instability

92.6%

14–20
High Instability

Intention to discuss treatment with a prescriber after completing SODA rises from 60% in the most stable group to 92.6% in the highest instability group — indicating SODA may help prompt discussion, particularly among those reporting greater instability.

Peer-Reviewed Publication

Medication Treatment Stability in Opioid Substitution Treatment: A Pilot Evaluation of SODA

Bonenti B, Masterton W, Gittins R, Matheson C, Piatkowski T, Ferris J, Kill E, Winstock AR

Submitted to Drug and Alcohol Review, 2026. N=1,063 across three community OST services in England and Wales.

Medications Covered

Works across all OST formulations

SODA produces a consistent 0–20 stability score across all medication types, with medication-specific wording, time anchors, and feedback. SODA v2 is currently under development.

💊

Methadone

Daily liquid or tablet. Full opioid agonist. SODA assesses whether the dose feels adequate across the usual daily dosing interval — including withdrawal, craving and any on-top use.

🔵

Oral Buprenorphine

Sublingual daily. Partial agonist. Ceiling effect. Precipitated withdrawal risk highlighted. Sublingual administration check included in safety questions.

💉

Weekly Depot

Buvidal weekly. SODA assesses how the person is experiencing the full 7-day period — including any withdrawal, craving or on-top use. Build-up phase and supplementary dose pathway acknowledged.

🗓️

Monthly Depot

Buvidal monthly. SODA assesses how the person is experiencing the 25–35 day interval — including withdrawal, craving and any on-top use. Stabilisation timeline and transition from weekly explained.

Audio button — bypasses health literacy barriers; patients can listen rather than read

Long-acting injectable buprenorphine — weekly and monthly depot formulations fully accommodated

Longitudinal tracking — patients can track themselves across services, medications, and settings over time

Community and prison delivery — adapted question sets for custodial settings; hypothetical framing where access is restricted

Readiness to reduce tool — supports patients wishing to reduce their dose or come off OST

Educational videos — treatment information with a specific focus on women in treatment

Prison pre-release module — identifies what patients in prison want and need to help them stay in treatment on release

Adherence domain — added as eighth question, scored 0–2, across all medications

Research Programme

Academic team and credentials

SODA v2 will be launched in the UK in July 2026, with a pilot version launching in Australia in October 2026. We are currently applying for an Innovate UK Contracts for Innovation Grant. The team spans expertise in psychiatry, addiction medicine, clinical practice, biostatistics and psychometrics, implementation science, and criminology.

Clinical Lead

Prof Adam Winstock

Director, Staying Safer Limited

Consultant Addiction Psychiatrist · PPG & Spectrum CiC

Over 200 publications in addiction research. Developer of SODA and Global Drug Survey. Specialist expertise in OST delivery across community and prison settings. Declared commercial interest managed through independent academic oversight of all evaluation workstreams.

Psychometrics

Prof Anna Brown

Lead Psychometrician

Independent · International Expert

International expert in psychometric modelling and construct validation. Leads item response theory modelling, reliability analysis, and cross-medication validation of SODA stability bands.

Implementation Science

Prof Carl May

Implementation Science Lead

London School of Hygiene & Tropical Medicine

Originator of Normalisation Process Theory and the SPRINT adoption model. Leads evaluation of adoption, behavioural impact, and implementation fidelity across community and prison sites.

Biostatistics

Prof Michael Lynskey

Lead Biostatistician

Independent · Internationally Recognised

Internationally recognised in addiction epidemiology and longitudinal modelling. Leads within-person trajectory analysis linking stability scores to dose change, retention, and post-release continuity.

Prison Health & Criminology

Prof Katy Holloway & Prof Catriona Matheson

Prison Feasibility Leads

University of South Wales · University of Stirling

Expertise in criminology, prison health, and national drug policy. Lead the discrete prison R&D workstream including pre-release stability assessment and continuity barrier identification.

Health Economics

IHE Health Economist

Independent Economic Evaluation

Swedish Institute for Health Economics

Independent economic evaluation using marginal cost-effectiveness methods, linking stability improvements to downstream system value including reduced overdose cost, improved retention, and dose optimisation.

🛡️

Independent Clinical Safety Officer

Dr Stephen Kaar

Consultant Addiction Psychiatrist · Northern Manchester NHS Trust · DCB0129/0160 clinical safety framework

Implementation Partner

Scottish Drugs Forum

National third-sector organisation responsible for site onboarding, training, peer engagement, and workflow integration across community and prison services. SDF's operational independence from Staying Safer Limited ensures implementation findings are not subject to developer influence.

Patient Resources

Understanding your medication

Plain-language information to help people in opioid treatment understand how their medication works, what to expect, and what to do if things aren't going well.

OST Medication Comparison

Question	Methadone Usual range: 60–100mg/day	Buprenorphine Tablets Usual range: 8–16mg/day	Depot Buprenorphine Usual range: 24–32mg/week or 96–128mg/month
How it works / how you take it	You swallow it. Higher doses build up tolerance, reducing withdrawal, craving and making on-top use a waste of money. Peak effect 3–4 hours after dose.	Dissolves under your tongue (tablets) or on top of it (Espranor). Sits on the same receptor as heroin and blocks the effect. Peak effect 30–60 minutes after dose.	Injection under your skin. Works like the tablets. The amount in your body builds over the first few months.
Do you need to be in mild withdrawal before starting?	No.	Yes. Leave at least 10 hours after last heroin use, or 24–36 hours after methadone (depends on dose — best to be under 20–30mg before switching).	Yes. Same as tablets. Not started if you appear sedated or intoxicated because of overdose risk.
Usual starting dose	10–30mg	4–8mg	16mg
How often do you take it?	Once a day.	Once a day (or every other day on bigger doses).	Weekly, then after 3–4 weeks, once a month.
Risks when you start	Over-sedation risk is higher with alcohol, benzos, pregabalin etc. If you feel sick, very sweaty, stoned or sedated after a dose, tell your prescriber — you may be on too much. Start low, go slow.	Precipitated withdrawal if taken when opioid is still in your system. Check liver function tests (LFTs).	Precipitated withdrawal if taken when opioid is still in your system.
How quickly can your dose go up?	Usually every 3–4 days, by 5–10mg each time, based on prescriber assessment.	Each day by 4–8mg, up to a maximum of 18–32mg depending on formulation.	Increases of 8–32mg depending on whether weekly or monthly injection.
How long to feel stable / stop withdrawals?	2–4 weeks	3–4 days (bigger doses last longer)	1–2 weeks
What if you miss a dose?	You might go into withdrawal. If you miss 3 or more doses you will need a prescriber review and your dose will be reduced and built up again over a few days or weeks.	You might go into withdrawal. Same prescriber review process as methadone if 3 or more missed.	You might go into withdrawal. Best to get the next injection before that happens — your prescriber may consider increasing your dose.
How long does a single dose last?	Usually at least 24 hours or more if you're on the right dose.	Can be 2–3 days on bigger doses.	1 week or 4 weeks, depending on injection type.
Benefits of increasing your dose	Increasing your dose can reduce withdrawal, craving and on-top use, and you might feel better. But remember: too much methadone can make you feel sick, sleepy and increases overdose risk.
What if your dose is not enough?	You will experience withdrawal between doses, feel cravings, and be more likely to use on top — and more likely to feel the effects of on-top use. Increasing your dose will help.
Common side effects	Sedation, nausea, sweating in hot weather, constipation, dry mouth, craving sweet things. If you feel sedated, tell your prescriber — your dose may be too high.	Anxiety, insomnia, headache, nausea, dry mouth, craving sweet things.	Pain and redness at injection site, plus those seen with buprenorphine tablets.
Supervised dosing requirements?	Yes, usually for the first 4 weeks.	No supervised doses.	Given at clinic — no home dosing.
How often do you see your keyworker / prescriber?	Maybe once or twice in the first week, then weekly or monthly as your dose stabilises.	2–3 times in the first week, then usually weekly or fortnightly over the first month. After that, every 4–8 weeks once your dose is stable, depending on how you are and what else the service can help with.

This table provides general information about OST medications. It does not constitute medical advice and should not be used to make decisions about your treatment. Always discuss any concerns about your medication with your prescriber or keyworker.

Safety & Compliance

Regulatory position & clinical safety

This page sets out SODA's regulatory classification, clinical safety framework, and the boundaries of the tool's intended use.

What SODA is

A structured self-report tool designed to support reflection and communication about opioid treatment experience.

SODA enables individuals to describe how their treatment feels day to day — including withdrawal, craving, ongoing opioid use and missed doses — and presents this information in a structured format to support discussion with their care team.

Individual responses are always shown alongside the summary score. SODA does not interpret data to guide clinical decisions. It summarises user-reported responses and presents them to support conversation.

What SODA does not do

❌Provide medical advice

❌Recommend treatment or dose changes

❌Perform diagnosis or risk stratification

❌Determine urgency of clinical review

❌Generate alerts, prompts, or automated clinical actions

Clinical responsibility

Clinical interpretation and all treatment decisions remain the responsibility of the prescribing clinician.

SODA is not intended to be used to make or inform clinical decisions.

SODA does not prioritise, triage, or recommend clinical review.

Regulatory Classification — MHRA

SODA is designed as a reflection and communication tool and is not intended for a medical purpose as defined under current guidance from the Medicines and Healthcare products Regulatory Agency.

A formal regulatory classification enquiry was submitted to the MHRA Innovation Office in March 2026. Staying Safer Limited will update this page when a formal classification response is received.

Clinical Safety Framework

DCB0129 / DCB0160

Clinical safety standards applied throughout development and deployment. Hazard log and clinical safety case in place.

Independent Clinical Safety Officer

Dr Stephen Kaar

Consultant Addiction Psychiatrist · Northern Manchester NHS Trust · Independent of Staying Safer Limited.

Questions about SODA's regulatory position? Contact us at data@stayingsafer.com

Is your opioid treatment working as well as it could?