Mobile telephone contingency management to encourage adherence to supervised medication among individuals receiving opioid agonist treatment: a feasibility study (TIES2)

Research question Is it feasible to conduct a future confirmatory trial to assess the clinical and cost effectiveness of delivering contingency management (CM) by mobile telephone (mCM) to encourage adherence with supervised methadone/buprenorphine in community pharmacies? Background Most individuals receiving opioid agonist treatment (OAT) are prescribed methadone or buprenorphine.

Supervision of methadone/buprenorphine by a pharmacist ensures that individuals take their correct dose every day to, i) minimise withdrawal and craving, ii) safeguard against diversion and overdose, and iii) receive optimum dose and benefit from OAT. Supervision is targeted at patients not adhering to their medication.

If a patient misses three doses, they must return to the drug service to have their dose re-titrated and receive a new prescription. This costs drug services time and resources. Missed doses should be reported by the pharmacist to a prescriber but reporting is inconsistent. There is an urgent need to develop effective interventions for medication adherence.

Research suggests that incentive-based medication adherence interventions (ie. CM) may be effective, but there are few trials and the provision of incentives in pharmacies can be challenging. The investigators have developed the technology to deliver mCM and alert prescribers of missed doses.

They found it was feasible to deliver and acceptable to patients, prescribers and pharmacists, but had difficulty recruiting sufficient numbers of patients starting methadone treatment. Since COVID-19, supervision guidelines have changed to focus on patients missing doses.

We want to conduct a further study to assess the feasibility of recruiting this revised patient group, with a broader eligibility criteria to include buprenorphine treatment.

Aims and objectives To assess the feasibility of conducting a future confirmatory trial to assess the clinical and cost effectiveness of mCM to encourage adherence with supervised methadone/ buprenorphine.

This 15-month study, will build on the previous feasibility trial to i) answer outstanding feasibility questions; ii) target a revised patient group of serial re-starters; and iii) address new questions arising from recent changes in supervision.

Methods Using a cluster randomised trial design, three drug services (each with seven pharmacies supervising methadone/buprenorphine to 20 individuals) will be recruited and randomly allocated (1:1:1) to either: i) mCM (CM delivered via text-message); ii) mR (reminders delivered via text-message); or iii) TAU (Treatment as usual), where participants receive no text-messages.

Financial incentives will be delivered by a pre-paid debit card system. Prescribers will receive reports of patient s attendance. Acceptability, recruitment, follow-up, and suitable measures of medication adherence will be assessed.

Anticipated impact and dissemination This study will inform the design of a future confirmatory trial to assess the clinical and cost effectiveness of mCM to encourage adherence to supervised methadone/buprenorphine among a clinically important group of patients non-adhering to their medication.

If found to be effective, mCM will i) encourage patients to adhere to their medication, achieve an optimum dose and full benefit from OAT, leading to increased potential to become opioid abstinent; ii) reduce the resource and costs of re-presentations for dose assessments; and iii) provide regular reports of missed doses to prescribers.