Testing a new intervention to support people who are dependent on opiate and benzodiazepine drugs
| ISRCTN | ISRCTN95130898 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95130898 |
| IRAS number | 304108 |
| Secondary identifying numbers | IRAS 304108, CPMS 53238 |
- Submission date
- 18/10/2023
- Registration date
- 23/10/2023
- Last edited
- 10/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Scotland has the highest rate of drug-related deaths in Europe. It is a feature of deaths in Scotland that people use combinations of drugs which increases the chance of a drug-related death. Many of these combinations involved benzodiazepine drugs which come from illegal sources. People who use opiates can be prescribed a safer replacement drug (e.g. methadone). Guidance on the management of benzodiazepine use highlights that there is little evidence to support replacement prescribing. However, the evidence is conflicting. This study aims to test a new intervention, designed by consulting people who use ‘street’ benzodiazepines and clinicians.
Who can participate?
Anyone over who is being treated for opiate dependence in a specialist addiction clinic but is also using illicit, unregulated 'street' benzodiazepines
What does the study involve?
The intervention is a combination of prescribed diazepam as a safer supply alongside psychosocial support which targets the motivations for use. Questionnaires and interviews will be used to assess whether the intervention is feasible.
What are the possible benefits and risks of participating?
The benefits could be better support to deal with the reasons people use illicit benzodiazepines and hopefully a move away from using these highly risky drugs. The risks are that any benzodiazepine alongside an opiate brings a risk of sedation and respiratory depression (slow and ineffective breathing).
Where is the study run from?
University of Stirling (UK)
When is the study starting and how long is it expected to run for?
May 2021 to August 2023
Who is funding the study?
The Chief Scientist Office of the Scottish Government (UK)
Who is the main contact?
Prof. Catriona Matheson, catriona.matheson@stir.ac.uk
Contact information
Public, Scientific, Principal Investigator
Bolmont Building
Stirling University Campus
Stirling
FK9 4LA
United Kingdom
 ORCID ID |
0000-0002-7568-1125 |
|---|---|
| Phone | +44 (0)7870135667 |
| catriona.matheson@stir.ac.uk |
Study information
| Study design | Single-arm feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Other |
| Study type | Prevention, Quality of life, Treatment, Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Developing an intervention to manage benzodiazepine dependence and high-risk use in the context of escalating drug deaths: a feasibility study |
| Study hypothesis | This was a feasibility study to test an intervention aimed at reducing the harmful use of illicit benzodiazepines in people also being treated for opiate dependence. |
| Ethics approval(s) |
Approved 29/10/2021, North of Scotland Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; +44 (0)1224 558458; gram.nosres@nhs.scot), ref: 21/NS/0135 |
| Condition | High-risk illicit drug use |
| Intervention | The intervention tested was a prescription of diazepam at a maximum dose of 30 mg, and a fortnightly nurse session addressing: anxiety, sleep and pain management and harm reduction support to reduce high-risk use of illicit drugs. Duration: 6 months for intervention and follow-up. |
| Intervention type | Mixed |
| Primary outcome measure | Use of illicit benzodiazepines measured using self-report and oral fluid testing monthly during the study |
| Secondary outcome measures | 1. Cognitive ability assessed using Addenbrooke's Cognitive Evaluation (ACE III) at baseline & follow-up (6 months) 2. Quality of life assessed using EQ5D-5L monthly during the study 3. Anxiety assessed using General Anxiety Disorder (GAD-7) at baseline & follow-up (6 months) 4. Depression assessed using Patient Health Questionnaire-9 (PHQ-9) at baseline & follow-up (6 months) 5. Self-assessed substance use recovery assessed using SURE questionnaire at baseline & follow-up (6 months) 6. Economic evaluation using NHS service use questionnaire completed monthly during the study 7. Satisfaction with professional care assessed using Consultation and Relational Empathy Measure (CARE) at follow-up (6 months) |
| Overall study start date | 01/05/2021 |
| Overall study end date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 39 |
| Participant inclusion criteria | 1. People in NHS drug treatment services who have achieved a stable dose of ORT (methadone or buprenorphine) 2. Have the capacity to provide informed consent 3. Experiencing ongoing risk of harm from street benzodiazepine use. ‘Risk of harm’ was defined as: an overdose event in the last 6 months in which a street benzodiazepine was implicated (from toxicology or clinical profile) and/or persistent self-report of daily street benzo use that is confirmed by toxicology screening and/or self-report of regular use of high doses/quantities of street benzodiazepines |
| Participant exclusion criteria | 1. Co-occurring harmful alcohol use 2. Co-occurring harmful stimulant use 3. Pregnancy 4. Participation in any other research study 5. Diagnosed serious mental illness or severe cognitive impairment that clinical staff consider poses a risk to safety (of patient or staff) 6. Non-English speaking 7. People who do not have the capacity to provide informed consent 8. ‘Harmful’ alcohol or stimulant use was use at a level in which it was the dominant problem for that individual |
| Recruitment start date | 01/05/2022 |
| Recruitment end date | 30/06/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centres
Aberdeen
AB25 2ZH
United Kingdom
Cameron Bridge
Windygates
Windygates
KY8 5RR
United Kingdom
Edinburgh
EH3 9DU
United Kingdom
Sponsor information
University/education
Bolmont Building
Stirling University Campus
Stirling
FK9 4LA
Scotland
United Kingdom
| Phone | +44 (0)1786 473171 |
|---|---|
| rachel.beaton@stir.ac.uk | |
| Website | https://www.stir.ac.uk/ |
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Three publications are planned: 1. A feasibility trial description 2. A qualitative paper describing the experiences of the intervention 3. Description of the intervention development process |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be available on request from Catriona Matheson (catriona.matheson@stir.ac.uk). The type of data that will be shared: the dataset of the outcome measure data collection could be shared on request. Dates of availability: after publication, not known precisely when that will be. Whether consent from participants was required and obtained: not obtained but it will be anonymised at the point of sharing. Comments on data anonymization: the data is anonymised and uses a study participant ID. However, it will need further removal of site to a site ID. |
Editorial Notes
10/06/2024: The following changes were made:
1. Total final enrolment was changed from 41 to 39.
2. The intention to publish date was changed from 01/12/2023 to 30/10/2024.
02/11/2023: Internal review.
23/10/2023: Study's existence confirmed by Chief Scientist Office, Scottish Government Health and Social Care Directorate.
