RecruitingPhase IIIInterventional

Benzodiazepine intervention in adults receiving opioid agonist treatment

This study aims to discover if a steady prescription of diazepam (a type of tranquiliser), combined with supportive care, can help adults receiving treatment for opioid addiction to stop using dangerous street benzodiazepines. Many people receiving opioid addiction treatment also use non-prescribed benzodiazepines, which are often connected to drug-related deaths. Street benzodiazepines can be much stronger than expected or contain unknown substances, leading to serious harm or overdose. The study will compare this new approach to the usual care, which typically involves gradually reducing diazepam doses. Researchers hope to find a safer, more effective way to help people reduce street benzodiazepine use and improve their health.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Stirling

Enrolment target

230

Start

01 Apr 2026

Estimated completion

31 Dec 2026

Medical condition: Adults enrolled in OAT (Opioid Agonist Treatment) with DSM-5-diagnosed substance (benzodiazepine) use disorder with toxicologically verified non-prescription benzodiazepine use in the previous month. Medical condition in lay language: Adults who are enrolled in Opioid Agonist Treatment programme (methadone or buprenorphine) who are using non-prescribed (street) benzodiazepine. Therapeutic areas: Psychiatry and Psychology [F] - Behaviours [F01]

What is this study about?

Benzodiazepines are medicines that some doctors prescribe for a short time to help with anxiety or sleep problems. However, many people who are receiving treatment for opioid addiction (like methadone or buprenorphine) also use benzodiazepines they buy illegally on the street. These street drugs are very risky because they can be much stronger than expected, or they might contain unknown ingredients, which can lead to serious health problems, blackouts, overdose, or even death. In the UK, there's been a worrying increase in drug-related deaths linked to these street benzodiazepines.

While there are good treatments for opioid addiction, there isn't a similar clear treatment path for people also struggling with benzodiazepine dependence. This study is trying to change that. Researchers have worked with people who have experience using benzodiazepines and with medical staff to develop a new approach. This approach involves providing a steady, prescribed dose of diazepam (a type of benzodiazepine) along with extra support. This support aims to help people understand and deal with the reasons they use benzodiazepines, such as anxiety, past difficult experiences, sleep problems, or pain. It also includes important information about the dangers of street benzodiazepines.

This study will compare this new approach to the current 'standard care'. Standard care usually involves slowly reducing a person's diazepamdose over a maximum of six months. Half of the people taking part in the study will receive the new approach, and the other half will receive standard care. Researchers will carefully monitor if the new approach helps people reduce their use of street benzodiazepines and if it's a safe and effective way to support them.

Key takeaways

A new way to help people using street benzodiazepines alongside opioid addiction treatment.
Compares a steady prescribed diazepam dose with extra support to usual care.
Aims to reduce the use of dangerous street benzodiazepines.
Involves regular checks for street drug use and discussions about well-being.
Funded by the National Institute for Health and Care Research (NIHR).

Who may be eligible?

This study is looking for adults aged 18 and older who are currently receiving treatment for opioid addiction (like methadone or buprenorphine). You must also have used non-prescribed benzodiazepines (drugs bought on the street) in the last month, which will be checked through a sample, and have a recognised problem with benzodiazepine use.

There are some reasons why you might not be able to join. For example, you can't participate if you also have a problem with alcohol, if you're already prescribed a benzodiazepine, or if you've had a prescription for one in the last month. The study also cannot include pregnant or breastfeeding individuals, people who don't speak English, or those with severe mental health conditions or significant memory/thinking problems.

Also, if diazepam isn't suitable for you due to other health reasons, or if you're unable to give your consent to take part, you wouldn't be able to join. The main goal is to involve people who are at risk of harm from using street benzodiazepines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Are you currently receiving methadone or buprenorphine for opioid addiction?
Have you used non-prescribed benzodiazepines (street drugs) in the last month?
Do you have a recognised problem with benzodiazepine use?
Are you able to speak English and understand the study information?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue with your current opioid addiction treatment. You'll be placed into one of two groups: one receiving a steady, prescribed dose of diazepam (between 16-30mg) plus extra support, and the other receiving standard care, which involves a gradual reduction of diazepam over several months. You won't know which group you are in, and neither will the study team.

Every month, you'll have a mouth swab taken to check for street drugs. You'll also be asked about your drug and alcohol use. Every six months for a year, information will be collected on your anxiety, mood, memory, and how you feel about your treatment. The treatment part of the study will last for 15 months, and the total data collection will take 12 months. Some participants and staff will also be interviewed at 3 months and 12 months to understand their experiences.

This study will involve regular visits for assessments and to receive medication, lasting for a total of 15 months for the intervention, with the main follow-up for outcomes over 12 months.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by helping you reduce your reliance on dangerous street benzodiazepines, which carry high risks of overdose and unknown substances. The extra support offered might also help address underlying issues. However, as with any medication, there can be side effects from diazepam, and your medical team will monitor you closely. There's also no guarantee that the new treatment will be more effective than standard care. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Angus Integrated Drugs and Alcohol Recovery Service (AIDARS)
City only
Arbroath, Scotland
Aberdeenshire Alcohol and Drug Service
City only
Peterhead, Scotland
South Alcohol and Drug Recovery Service
City only
Glasgow, Scotland
Change, Grow, Live
City only
Sunderland, England
Turning Point
City only
Yeovil, England

Common questions

What are street benzodiazepines?

These are benzodiazepine drugs bought illegally that haven't been prescribed by a doctor. They are risky because they might be stronger than expected or contain unknown, dangerous substances.

What is Opioid Agonist Treatment (OAT)?

OAT is a treatment for opioid addiction, usually involving medicines like methadone or buprenorphine, prescribed by a doctor to help people manage their addiction safely.

What is the difference between the two treatments in the study?

One group gets a steady, prescribed dose of diazepam with extra support to address the reasons behind benzodiazepine use. The other group gets standard care, which means a slowly decreasing dose of diazepam.

How will the study check for street drug use?

Researchers will use monthly mouth swabs, which are tested in a lab, and ask you directly about your drug and alcohol use.

Where is the study taking place?

The study will be run at several locations across Scotland and England, managed by the University of Stirling.

How to find out more

Christine Kennedy

inboat@abdn.ac.uk +44 (0)1224 438189 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.