Mobile telephone delivered contingency management for encouraging adherence to supervised methadone consumption: feasibility study for an RCT of clinical and cost-effectiveness (TIES).

BACKGROUND: Prescription methadone or buprenorphine enables people with opioid use disorder to stop heroin use safely while avoiding withdrawal. To ensure methadone is taken as prescribed and to prevent diversion onto the illicit market, people starting methadone take their daily dose under a pharmacist's supervision. Many patients miss their daily methadone dose risking withdrawal, craving for heroin and overdose due to loss of heroin tolerance. Contingency management (CM) can improve medication adherence, but remote delivery using technology may be resource-light and cost-effective. We developed an innovative way to deliver CM by mobile telephone. Software monitors patients' attendance and supervised methadone consumption through an internet self-login at the pharmacy and sends reinforcing text messages to patients' mobile telephones. A linked system sends medication adherence reports to prescribers and provides early warning alerts of missed doses. A pre-paid debit card system provides financial incentives. METHODS: A cluster randomised controlled trial design was used to test the feasibility of conducting a future trial of mobile telephone CM to encourage adherence to supervised methadone in community pharmacies. Each cluster (drug service/3 allied pharmacies) was randomly allocated to provide patient's presenting for a new episode of opiate agonist treatment (OAT) with either (a) mobile telephone text message CM, (b) mobile telephone text message reminders, or (c) no text messages. We assessed acceptability of the interventions, recruitment, and follow-up procedures. RESULTS: Four drug clinics were approached and three recruited. Thirty-three pharmacists were approached and 9 recruited. Over 3 months, 173 individuals were screened and 10 enrolled. Few patients presented for OAT and high numbers were excluded due to receiving buprenorphine or not attending participating pharmacies. There was 96% consistency in recording medication adherence by self-login vs. pharmacy records. In focus groups, CM participants were positive about using self-login, the text messages, and debit card. Prescribers found weekly reporting, time saving, and allowed closer monitoring of patients. Pharmacists reported that the tablet device was easy to host. CONCLUSION: Mobile telephone CM worked well, but a planned future trial will use modified eligibility criteria (existing OAT patients who regularly miss their methadone/buprenorphine doses) and increase the number of participating pharmacies. TRIAL REGISTRATION: The trial is retrospectively registered, ISRCTN 58958179 .

Positive reinforcement targeting abstinence in substance misuse (PRAISe): Study protocol for a Cluster RCT & process evaluation of contingency management.

There are approximately 256,000 heroin and other opiate users in England of whom 155,000 are in treatment for heroin (or opiate) addiction. The majority of people in treatment receive opiate substitution treatment (OST) (methadone and buprenorphine). However, OST suffers from high attrition and persistent heroin use even whilst in treatment. Contingency management (CM) is a psychological intervention based on the principles of operant conditioning. It is delivered as an adjunct to existing evidence based treatments to amplify patient benefit and involves the systematic application of positive reinforcement (financial or material incentives) to promote behaviours consistent with treatment goals. With an international evidence base for CM, NICE recommended that CM be implemented in UK drug treatment settings alongside OST to target attendance and the reduction of illicit drug use. While there was a growing evidence base for CM, there had been no examination of its delivery in UK NHS addiction services. The PRAISe trial evaluates the feasibility, acceptability, clinical and cost effectiveness of CM in UK addiction services. It is a cluster randomised controlled effectiveness trial of CM (praise and financial incentives) targeted at either abstinence from opiates or attendance at treatment sessions versus no CM among individuals receiving OST. The trial includes an economic evaluation which explores the relative costs and cost effectiveness of the two CM intervention strategies compared to TAU and an embedded process evaluation to identify contextual factors and causal mechanisms associated with variations in outcome. This study will inform UK drug treatment policy and practice. Trial registration ISRCTN 01591254.

Pathways into receiving a prescription for diamorphine (heroin) for the treatment of opiate dependence in the United kingdom.

In the UK, few doctors prescribe diamorphine for the treatment of opiate dependence to a small number of patients. A retrospective case note review of patients receiving diamorphine in 2000 was conducted in the UK to determine how and why these patients came to receive a prescription for diamorphine. Patient eligibility criteria were examined together with doctors' stated reasons for initiating a diamorphine (heroin) prescription. Two hundred and ten sets of patients' case notes were reviewed at 27 of the 42 (64%) drug clinics in England and Wales where diamorphine was prescribed by the doctor. There appeared to be a general consensus among the few doctors who had prescribed diamorphine that it was a treatment of last resort, for those with long histories of heroin use and injecting, and those who had not responded sufficiently well to previous other treatments. However, there was also a small number of patients initiated on diamorphine without ever having previously received opiate treatments and some because they were experiencing problems injecting methadone. This reflects the UK history of the individual doctor's clinical autonomy in deciding when diamorphine is appropriate and the previous lack of nationally agreed patient eligibility criteria.

Patients receiving a prescription for diamorphine (heroin) in the United Kingdom.

The United Kingdom is unusual internationally in that it is one of few countries able to prescribe diamorphine for the treatment of opiate dependence. Prescribing diamorphine has been part of the UK response to drug problems since the 1920s. Despite this, little is known about who receives diamorphine and how treatment is delivered. This study aims to describe the characteristics and treatment regimes of opiate-dependent drug users receiving a prescription for diamorphine in the United Kingdom in 2000, and report on their status in 2002. A retrospective case-note review was conducted in England and Wales. Two hundred and ten (72%; 210/292) patients' sets of case-notes were reviewed at 27 of the 42 (64%) drug clinics where diamorphine was prescribed by the doctor. Patients had been receiving a prescription for diamorphine for a median length of six years. The majority were unemployed white males, with a median age of 44 years. Illicit drug use and criminal activity, while low, had not been eliminated totally. The majority were prescribed ampoules and few had significant health problems. In some cases patients had been transferred to injectable diamorphine from injectable methadone to reduce injection related problems. There were wide variations in dose. The majority of patients had no serious drug, health or social problems. Diamorphine prescribing was a long-term commitment. The experience from the United Kingdom has been one of long-term prescribing with the aim of retaining patients in treatment and reducing the harms caused by illicit drug use. Prospective studies are needed to determine the long-term consequences of receiving a diamorphine prescription.

Feasibility of prescribing injectable heroin and methadone to opiate-dependent drug users: associated health gains and harm reductions.

OBJECTIVE: To assess the feasibility of offering the choice of prescribing injectable heroin (diamorphine) or injectable methadone to opiate-dependent injecting drug users and to assess whether there are health and social gains associated with prescribing injectable opiates. DESIGN: A protocol-driven prospective observational study. Type of injectable opiate received was based on self-selection. SETTING: A large west London drug clinic. PATIENTS: Fifty-eight patients admitted to the clinic between 1 June 1995 and 31 December 1996, who were long term opiate-dependent injecting drug users, who had previously tried and failed oral methadone and who were apparently unable or unwilling to give up injecting. MAIN OUTCOME MEASURES: Retention in treatment, illicit drug use, HIV risk behaviour, criminal activity, social functioning, health and psychological status as measured by self-report, urinalysis and doctor's ratings. RESULTS: Thirty-seven patients (64%) chose heroin and 21 (36%) chose injectable methadone. Fifty (86%) were retained in treatment after three months, 40 (69%) after six months and 33 (57%) after 12 months. Among those in treatment at three months, there were significant reductions in illicit drug use, illicit drug-injecting risk behaviour, and criminal activity, and significant improvements in social functioning, health status and psychological adjustment. Generally, these gains were sustained between three, six and 12 months. Doctors' ratings of health and urinalysis results further supported these findings. CONCLUSIONS: Injectable heroin is not always the drug of choice. This intervention retained most patients in treatment with substantial benefits to both patients and the community. Prescribing injectable opiates to long term injecting drug users is a feasible treatment option.

Who should collect Opiate Treatment Index data in opiate treatment outcome monitoring: clinic staff or researchers?

The Opiate Treatment Index (OTI), an instrument designed to monitor treatment outcome of opioid users, is becoming increasingly popular among clinicians and researchers in the United Kingdom. This study was designed to examine how the OTI would perform when administered by clinic staff compared to externally contracted researchers in clinical settings. In a confidential setting, the OTI was administered twice to 55 opioid users from two London clinics, in a random fashion, once by trained clinic staff and once by researchers within a 2-week period. The data generated by both groups were similar with respect to social functioning, physical health and psychological adjustment. Where differences occurred, in almost all the cases they were not statistically significant. Clients reported slightly higher levels of drug use episodes, injecting behaviour and criminal activity to researchers. In both groups, none of the clients admitted to paid sex, and low levels of criminal activity and illicit drug use are reported-findings which are most probably related to the stability of these patients rather than systematic under-reporting. Although this cross-sectional study showed that the OTI could be applied equally effectively by clinic staff and researchers in clinical settings, further research is needed to examine whether the situation would hold true in routine outcome monitoring. To ensure that reliable and valid data are generated in routine monitoring of treatment programmes, several issues relating to clinic staff (e.g. motivation, time); clients (e.g. co-operation, confidentiality) and researchers (e.g. cost) need to be addressed.