Opioid use disorder Mental and Behavioural Disorders
Conditions
Interventions
The aim is to determine the acceptability and feasibility of conducting a future randomised controlled trial of the clinical effectiveness of mobile telephone-delivered Contingency Management (mCM) to
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Receiving opioid agonist treatment (methadone or buprenorphine, including pro-longed release) 2. Self-reported heroin use at least 1 day/week 3. Aged >= 18 years 4. Able to operate an Android or iOS smartphone with acceptable capability 5. Willing to receive a 12-week CM intervention 6. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: Participating in any other research studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this feasibility trial is the number of eligible service users recruited over the 6-month recruitment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility outcomes include: 1. The number and percentage of screened service users eligible for inclusion and reasons for ineligibility recorded during the 6-month recruitment period 2. The number and percentage of eligible service users who consent to participate in the feasibility trial and the reasons for refusing consent recorded during the 6-month recruitment period 3. Adherence to the intervention based on app interactions, responses to push notifications, and uploads, recorded at recorded continuously during the 12-week intervention 4. The number/percentage attending follow-up interviews of those randomised, recorded at the end of the 12-week intervention 5. The number/percentage of oral saliva tests uploaded of sufficient quality, recorded continuously during the 12-week intervention 6. The number/percentage of urine samples conducted, collected at 4-weekly intervals following randomisation 7. Acceptability of the intervention among recipients exploring satisfaction and perceived benefits, assessed by qualitative interviews at the end of the 12-week intervention 8. Acceptability among treatment providers, exploring perceived appropriateness, intent for future adoption, and perceived positive or negative effects on service, assessed by qualitative interviews at the end of the 12-week intervention The primary clinical outcome measure for a future confirmatory trial is the percentage of heroin-negative urine samples collected at 4-week intervals following randomisation Secondary outcomes for the future confirmatory trial include: 1. Number/percentage retained in treatment over the 12-week intervention period 2. Drug use measured using the Opiate Treatment Index (Section 2 - Drug Use) at baseline, weeks 4, 8 and 12 3. Anxiety and depression states measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, weeks 4, 8 and 12 4. Social functioning measured using the Opiate Treatment Index at baseline, weeks 4, 8 and 12 5. Readiness t | — |
Countries
England, United Kingdom
Outcome results
None listed