Plain English Summary
Background and study aims
We are conducting a feasibility study to see if offering people who inject heroin same day access to a GP and a methadone script (called opium substitution treatment (OST)) can help these individuals get into and stay on OST. We are focusing upon individuals who find it particularly hard to engage in OST or those who have recently dropped out of treatment. The reason why we are conducting this study is because we know that accessing OST reduces the risk of drug related deaths and blood borne virus transmission.
Who can participate?
Individuals (male and female) accessing the Bristol Drugs Project (BDP) needle exchange are asked if they are interested in participating in this study. Participants are eligible if they are injecting opiates (heroin), live in Bristol and are not currently receiving a script of OST.
What does the study involve?
Participants who consent and complete questionnaires at baseline are randomised into two groups either to receive the intervention i.e., receive a script of methadone on the same day, or, 'care as usual' (offer to make an appointment with GP to start OST). All participants are followed up at three months, complete further questionnaires and asked if they are still on a script of OST at this time point.
What are the possible benefits and risks of participating?
Participants may benefit from having same day access to a script of methadone rather than waiting up to one to two weeks (longer in some areas) for a script. Participants will need to spend about 30 minutes filling in questionnaires and be available to go to an appointment at the recruiting GP practice on the same day. They will also need to return at one and then two weeks later to renew their script. No other risks associated with this study.
Where is the study run from?
The study is run from the University of Bristol in collaboration with the Bristol Drugs Project (BDP), Bristol.
When is the study starting and how long will it run for?
The study started participant recruitment in October 2011. The aim was to recruit for one year or when the target sample (100) was achieved. This was completed in September 2012.
Who is funding the study?
This study is funded by funded by the NHS via the National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB).
Who is the main contact?
Dr Angela Beattie
Angela.Beattie@bristol.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Angela Beattie
ORCID ID
Contact details
Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
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Angela.Beattie@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10169
Study information
Scientific title
SCript In a Day for injecting drug users: feasibility trial
Acronym
SCID
Study hypothesis
Script in a day (SCID) is an exploratory randomised controlled trial.
Key aims include:
1. To explore whether providing access to a GP and same day scripting of methadone opiate substitution treatment (OST) helps people who are injecting heroin to get into and stay on treatment.
2. To estimate some degree of benefit of receiving immediate access to a script in a day.
Ethics approval
NHS National Research Ethics Service, South West Rec 4, First MREC approval date 28/01/2011, ref: 11/H0102/1
Study design
Two-arm non-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Drug misuse, individuals injecting opiates, opiate substitution treatment (OST)
Intervention
Participants are randomised into two groups. All participants complete baseline questionnaires and at the 3 month follow-up.
The control group receive 'care as usual' (offer to make an appointment with GP to initiate OST).
The intervention group receive a script of methadone on the same day they are randomised. Participants are offered an appointment with the study GP and a BDP peer support worker is available if requested, to accompany participants to their first and subsequent appointments. Following a urine test confirming the presence of opiates, and, confirmation from participant's medical and drug treatment agency records they are not currently prescribed OST, methadone treatment is initiated. Participants return to see the study GP one week and two weeks later. At the end of this period participants are transferred to their own Shared Care Worker. If there are no spaces available participants are supported by the study shared care workers until a space becomes available.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Participants on a script of OST at three month follow-up
Secondary outcome measures
1. Number of participants eligible for the trial, recruitment and retention rates
2. The TOP scale is a widely used treatment outcomes profile measure in drug services which collects information about frequency and cost of substance use, injecting risk behaviour, health and social functioning and crime
3. EQ-5D is a generic measure, with 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and can be used to calculate quality-adjusted life years (QALY) for formal cost-effectiveness analyses
4. A health questionnaire (adapted from Medical Outcomes Study: 36-item short form survey by Rand) will also be used. This questionnaire measures quality of life and is based on 6 domains including physical function and well-being. Higher scores indicate better QOL
Overall trial start date
01/04/2011
Overall trial end date
30/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants are living in Bristol
2. Injecting opiates
3. Not currently prescribed OST
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
Participants already prescribed OST
Recruitment start date
01/10/2011
Recruitment end date
01/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
Bristol
BS8 2PR
United Kingdom
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme: PB-PG-0909-20007
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25407020
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/28158697