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Background: A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.Methods/design: Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.Discussion: This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.Trial Registration: http://www.comet-initiative.org/Studies/Details/1579. [ABSTRACT FROM AUTHOR]

Background and Aims People with opioid use disorder (OUD) in prison face an acute risk of death after release. We estimated whether prison-based opioid substitution treatment (OST) reduces this risk. Design Prospective observational cohort study using prison health care, national community drug misuse treatment and deaths registers. Setting Recruitment at 39 adult prisons in England (32 male; seven female) accounting for 95% of OST treatment in England during study planning. Participants Adult prisoners diagnosed with OUD (recruited: September 2010-August 2013; first release: September 2010; last release: October 2014; follow-up to February 2016; n = 15 141 in the risk set). Intervention and Comparator At release, participants were classified as OST exposed ( n = 8645) or OST unexposed ( n = 6496). The OST unexposed group did not receive OST, or had been withdrawn, or had a low dose. Measurements Primary outcome: all-cause mortality (ACM) in the first 4 weeks. Secondary outcomes: drug-related poisoning (DRP) deaths in the first 4 weeks; ACM and DRP mortality after 4 weeks to 1 year; admission to community drug misuse treatment in the first 4 weeks. Unadjusted and adjusted Cox regression models (covariates: sex, age, drug injecting, problem alcohol use, use of benzodiazepines, cocaine, prison transfer and admission to community treatment), tested difference in mortality rates and community treatment uptake. Findings During the first 4 weeks after prison release there were 24 ACM deaths: six in the OST exposed group and 18 in the OST unexposed group [mortality rate 0.93 per 100 person-years (py) versus 3.67 per 100 py; hazard ratio (HR) = 0.25; 95% confidence interval (CI) = 0.10-0.64]. There were 18 DRP deaths: OST exposed group mortality rate 0.47 per 100 py versus 3.06 per 100 py in the OST unexposed group (HR = 0.15; 95% CI = 0.04-0.53). There was no group difference in mortality risk after the first month. The OST exposed group was more likely to enter drug misuse treatment in the first month post-release (odds ratio 2.47, 95% CI = 2.31-2.65). The OST mortality protective effect on ACM and DRP mortality risk was not attenuated by demographic, overdose risk factors, prison transfer or community treatment (fully adjusted HR = 0.25; 95% CI = 0.09-0.64 and HR = 0.15; 95% CI = 0.04-0.52, respectively). Conclusions In an English national study, prison-based opioid substitution therapy was associated with a 75% reduction in all-cause mortality and an 85% reduction in fatal drug-related poisoning in the first month after release. [ABSTRACT FROM AUTHOR]

Aims To compare the change in illicit opioid users' risk of fatal drug-related poisoning (DRP) associated with opioid agonist pharmacotherapy (OAP) and psychological support, and investigate the modifying effect of patient characteristics, criminal justice system (CJS) referral and treatment completion. Design National data linkage cohort study of the English National Drug Treatment Monitoring System and the Office for National Statistics national mortality database. Data were analysed using survival methods. Setting All services in England that provide publicly funded, structured treatment for illicit opioid users. Participants Adults treated for opioid dependence during April 2005 to March 2009: 151 983 individuals; 69% male; median age 32.6 with 442 950 person-years of observation. Measurements The outcome was fatal DRP occurring during periods in or out of treatment, with adjustment for age, gender, substances used, injecting status and CJS referral. Findings There were 1499 DRP deaths [3.4 per 1000 person-years, 95% confidence interval (CI) = 3.2-3.6]. DRP risk increased while patients were not enrolled in any treatment [adjusted hazard ratio (aHR) = 1.73, 95% CI = 1.55-1.92]. Risk when enrolled only in a psychological intervention was double that during OAP (aHR = 2.07, 95% CI = 1.75-2.46). The increased risk when out of treatment was greater for men (aHR = 1.88, 95% CI = 1.67-2.12), illicit drug injectors (aHR = 2.27, 95% CI = 1.97-2.62) and those reporting problematic alcohol use (aHR = 2.37, 95% CI = 1.90-2.98). Conclusions Patients who received only psychological support for opioid dependence in England appear to be at greater risk of fatal opioid poisoning than those who received opioid agonist pharmacotherapy. [ABSTRACT FROM AUTHOR]

Aims The present study represents the first large-scale test of the capacity to predict illicit drug treatment outcomes of an instrument [Stages of Change and Treatment Eagerness Scale (SOCRATES)] purporting to measure processes underlying stages of change. The main hypothesis was that ‘taking steps’ should be predictive of less frequent use of illicit opiates (heroin and non-prescribed methadone) at follow-up. Design The sample comprised 1075 people seeking treatment for drug abuse problems in 54 treatment agencies in England. The study uses a longitudinal, prospective cohort design. Structured interviews were conducted at treatment intake and at 1-year follow-up. Data were collected about illicit drug use (frequency of use of heroin, non-prescribed methadone, cocaine and amphetamines, and non-prescribed benzodiazepines) and other problems. Findings Results failed to support the hypothesis that taking steps should be associated with less frequent use of illicit opiates at follow-up. No statistically significant associations of any kind were found between readiness for change measures and use of opiates or stimulants at follow-up. A negative association was found between taking steps and benzodiazepine misuse. Readiness for change measures were correlated with heroin use and psychiatric symptom scores at treatment intake. Conclusions Readiness for change measures were not associated with illicit drug use outcomes. Of the 12 hypothesized relationships between readiness for change measures and outcomes, our results show only one ‘hit’ and 11 ‘misses’. [ABSTRACT FROM AUTHOR]

The paper examines the demographic, drug use and offending profile of arrestees in contact with arrest referral (AR) schemes in London, compares these contacts with the arrestee population as a whole, and with drug users presenting to treatment services in the community, and assesses the proportion and characteristics of AR contacts that go on to attend drug-treatment services. Routine monitoring data from AR schemes (April 2000 to March 2001) were analysed and compared with data (for equivalent time period) on arrestees from the Crime Reporting Information System (CRIS) and data from the National Drug Treatment Monitoring System (NDTMS). AR schemes see about 10% of arrestees in London. Approximately half of those assessed by an AR worker report using heroin (55%) and crack cocaine (49%) with a similar proportion (51%) having no previous contact with drug-treatment services. The large majority (80%) report previous convictions. Of those referred by AR workers (50% of assessments) between 25 and 37% attend a first appointment at a drug-treatment service. Drug users seen by AR workers are younger, more likely to come from ethnic minorities and more likely to be using crack cocaine than those presenting to treatment services in the community. AR is a key point of contact with problem drug users, including those considered under-represented at drugtreatment services. However, to fully assess the effectiveness of AR, further information is required about retention in treatment and its effect on drug use and offending behaviour. [ABSTRACT FROM AUTHOR]

Focuses on the importance of identifying alcohol problems among methadone maintenance patients. Use of multiple strategies for assessing alcohol consumption, alcohol dependence and liver function tests; Provision of useful and satisfactory indicator of drinking behavior through self-reported alcohol consumption.

This paper describes treatment practices in 54 drug treatment programmes taking part in the National Treatment Outcome Research Study (NTORS). Programmes were representative of the 4 main treatment modalities in the UK: in-patient, residential rehabilitation, methadone maintenance and methadone reduction. Distinguishing features of these forms of treatment were identified. Substantial variations in treatment practices were also observed within each modality, particularly for detoxification and prescribing arrangements, counselling and non-drug treatment services, and planned duration of treatment. Many programmes reported extensive waiting lists. These findings are discussed in the context of the growing international evidence of the association between patient outcome and the manner in which programme services are delivered.Copyright © 2000 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background Criminal activity among drug-misusing populations can result in considerable costs. This paper examines the relationship between acquisitive criminal behaviour and drug use among a cohort of 1075 clients recruited to the National Treatment Outcome Research Study (NTORS). Method Clients were recruited from 54 drug misuse treatment programmes in England. A structured interview was administered by clinical staff. The majority of clients were opiate-dependent poly-drug users. Results Over 27 000 acquisitive criminal offences were reported by the cohort in the three months prior to starting treatment, of which shoplifting was the most common offence. There was marked variation in the amount of acquisitive crime reported; just 10% of the sample were responsible for three-quarters of the crimes committed. Two other groups were identified: low-rate offenders, and those who did not commit an acquisitive crime. Multivariate analyses revealed that frequency of illicit drug use was associated with increased levels of criminal behaviour. Compared with the no-crime group, the high-rate offenders were 11 times more likely to be regular users of heroin, and three times more likely to have used cocaine regularly. Discussion; These findings suggest that the most dependent and problematic drug misusers present treatment services with the greatest challenge in terms of reducing levels of criminality. [ABSTRACT FROM AUTHOR]

Aim. To develop a brief, multi-dimensional instrument for assessing treatment outcome for people with drug and/or alcohol problems. The Maudsley Addiction Profile (MAP) is the first instrument to be developed in the United Kingdom for this purpose. Design. Field testing with quota-recruitment of problem drug users and problem alcohol users in treatment with researcher and clinician-administered test-retest interviews. Setting. Two community and two inpatient services at the Bethlem Royal and Maudsley Hospital, London. Participants. Subjects (160 drug users and 80 alcohol users) interviewed by eight interviewers (four researchers and four clinicians), each of whom interviewed 30 subjects on two occasions. Measures. Sixty items across substance use, health risk, physical/psychological health and personal/social functioning domains. Findings. Average completion time of the MAP was 12 minutes. The questionnaire was acceptable to a majority of subjects and performed well with both researcher and clinician interviewers. Internal reliability and feasible concurrent validity assessments of the scales and items were highly satisfactory. Test-retest reliability was good, average intraclass correlation coefficients across eight substances were 0.94 and 0.81 across health risk, health problems, relationship conflict, employment and crime measures. Conclusions. The MAP can serve as a core research instrument with additional outcome measures added as required. The collection of a set of reliable quantitative measures of problems among drug and alcohol users by research or treatment personnel for outcome evaluation purposes need not be time-consuming. [ABSTRACT FROM AUTHOR]

The study investigated cannabis use among 200 opiate misusers attending out-patient treatment services at two sites. Three groups were classified according to the frequency of their cannabis use in the previous month; 40.5% were non-users, 40% daily users and the remaining 19.5% were classified as occasional users (they had used on between 1 and 29 days in the previous month). Non-users of cannabis had used heroin in the previous month on more occasions than either daily or occasional users (p< 0.001). Non-cannabis users also reported the highest average frequencies of use of alcohol (p< 0.01) and crack cocaine (p< 0.05). In contrast, daily users of cannabis reported more symptoms of anxiety (p< 0.01) and depression (p< 0.01) than either of the other groups. Finally, daily cannabis users were more likely to report dietary problems than either occasional users or non-users of cannabis. While cannabis use is highly prevalent among opiate misusers in treatment, its relationship to treatment outcome is complex and requires greater research scrutiny. \[Best D, Gossop M, Greenwood J, Marsden J, Lehmann P, Strang J. Cannabis use in relation to illicit drug use and health problems among opiate misusers in treatment. Drug Alcohol Rev 1999;18:31-38]. [ABSTRACT FROM AUTHOR]

Opioid substitution with oral methadone is the most widely implemented treatment for heroin dependence. In Britain, a complex array of specialist and generic health care services have evolved to deliver this treatment modality. Several minority aspects of British substitution practices receive enduring international interest, including the use of heroin itself as a substitute and the prescribing of methadone in an injectable form. This paper focuses on six linked dimensions that characterize substitution services: (1) treatment providers and settings, (2) prescribing regimes and treatment goals, (3) substitute drugs, (4) dose administration, (5) dose levels, and (6,) substitute formulations. Against a background of increasing central and local accountability for the quality and efficiency of specialist providers and critical attention toward their effectiveness, the strengths and weaknesses of the British approach are considered and key issues and future directions are discussed. [ABSTRACT FROM AUTHOR]

Background: This is the first national study in England of continuous long-term opioid substitution treatment (OST).Methods: All adults were admitted to community OST for opioid use disorder (OUD) in 2008/09 with continuous enrolment to 2013/14 (n = 7719). Heroin use trajectories were identified by multilevel Latent Class Growth Analysis. In Year 6 and 7 of follow-up, the outcome measure (analysed by multilevel, multivariable logistic regression) was 'successful completion and no re-presentation' (SCNR) to community treatment within six months.Results: Five heroin use trajectory classes were identified: 'gradual decreasing' (20.9%), 'decreasing then increasing' (21.7%), 'continued low-level' (17.0%), 'rapid decreasing' (25.6%), and 'continued high-level' (14.8%). At the end of Year 7, 4616 people (60.3%) remained in OST. Of those discharged, 28.8% achieved the SCNR follow-up outcome. SCNR was more likely in the 'gradual decreasing' (adjusted odds ratio [AOR] 2.40; 95% confidence interval [CI] 1.77-3.26), 'continued low-level' (AOR 2.46; CI 1.78-3.40), and 'rapid decreasing' (AOR 3.40; CI 2.43-4.37) classes relative to the 'continued high-level' class. SCNR was more likely among patients employed at admission (AOR 1.45; 95% CI 1.15-1.83) and those receiving adjunctive psychosocial interventions (AOR 1.44; 95% CI 1.03 to 2.02).Conclusions: Among English patients in OST for 5 years, heroin use trajectories were clearly delineated with a gradient of response on the study outcome. Successful completion and no re-presentation was achieved by 28.8% of discharged patients. The rapid decreasing trajectory had the greatest likelihood of positive outcome. Adjunctive psychosocial intervention during OST was associated with positive outcome. [ABSTRACT FROM AUTHOR]

Few studies have investigated methadone treatment of opiate dependent patients in primary health care settings. Using a prospective cohort design, the study investigated outcomes at 1 and 2 years for 240 patients treated by general practitioners (n = 79) or drug clinics (n = 161) at sites across England. Mean daily methadone dose for both groups was 50 mg. Reductions in illicit drug use, injecting, sharing injecting equipment, psychological and physical health problems, and crime, were found in both groups at follow-up. Patients treated in general practitioner (GP) settings reported less frequent benzodiazepine and stimulant use, and fewer psychological health problems at follow-up. Alcohol use outcomes were poor for both groups. Differences in treatment practices were found for GPs and clinics. Results show substantial reductions in a range of problems behaviours, among unselected samples of opiate dependent patients treated in GP and in clinic settings, which are sustained to 1-year and 2-year follow-up. [Copyright &y& Elsevier]