Daily methadone maintenance or buprenorphine treatment is the standard-of-care (SoC) medication for opioid use disorder (OUD). Subcutaneously injected, extended-release buprenorphine (BUP-XR) may be more effective—but there has been no superiority evaluation. This pragmatic, parallel-group, open-label, multi-centre, effectiveness superiority randomised, controlled, phase 3 trial was conducted at five National Health Service community-based treatment clinics in England and Scotland. Participants (adults aged ≥ 18 years; all meeting DSM-5 diagnostic criteria for moderate or severe OUD at admission to their current maintenance treatment episode) were randomly assigned (1:1) to receive continued daily SoC (liquid methadone (usual dose range: 60–120 mg) or sublingual/transmucosal buprenorphine (usual dose range: 8–24 mg) for 24 weeks; or monthly BUP-XR (Sublocade;® two injections of 300 mg, then four maintenance injections of 100 mg or 300 mg, with maintenance dose selected by response and preference) for 24 weeks. In the intent-to-treat population (senior statistician blinded to blinded to treatment group allocation), and with a seven-day grace period after randomisation, the primary endpoint was the count of days abstinent from non-medical opioids between days 8–168 (i.e., weeks 2–24; range: 0–161 days). Safety was reported for the intention-to- treat population. Adopting a broad societal perspective inclusive of criminal justice, NHS and personal social service costs, a trial-based cost-utility analysis estimated the Incremental Cost-effectiveness Ratio (ICER) per quality-adjusted life year (QALY) of BUP-XR versus SoC at the National Institute for Health and Care Excellence threshold. The study was registered EudraCT (2018-004460-63) and ClinicalTrials.gov (NCT05164549), and is completed. Between Aug 9, 2019 and Nov 2, 2021, 314 participants were randomly allocated to receive SoC (n = 156) or BUP-XR (n = 158). Participants were abstinent from opioids for an adjusted mean of 104.37 days (standard error [SE] 9.89; range: 0–161 days) in the SoC group and an adjusted mean of 123.43 days (SE 4.76; range: 24–161 days) in the BUP-XR group (adjusted incident rate ratio [IRR] 1.18, 95% confidence interval [CI] 1.05–1.33; p-value 0.004). The incidence of any adverse event was higher in the BUP-XR group than the SoC group (128 [81.0%] of 158 participants versus 67 [42.9%] of 156 participants, respectively—most commonly rapidly-resolving (mild–moderate range) pain from drug administration in the BUP-XR group (121 [26.9%] of 450 adverse events). There were 11 serious adverse events (7.0%) in the 158 participants in the BUP-XR group, and 18 serious adverse events (11.5%) in the 156 participants in the SoC group—none judged to be related to study treatment. The BUP-XR treatment group had a mean incremental cost of £1033 (95% central range [CR] −1189 to 3225) and was associated with a mean incremental QALY of 0.02 (95% CR 0.00–0.05), and an ICER of £47,540 (0.37 probability of being cost-effective at the £30,000/QALY gained willingness-to-pay threshold). However, BUP-XR dominated the SoC among participants who were rated more severe at study baseline, and among participants in maintenance treatment for more that 28 days at study enrolment. Evaluated against the daily oral SoC, monthly BUP-XR is clinically superior, delivering greater abstinence from opioids, and with a comparable safety profile. BUP-XR was not cost-effective in a base case cost-utility analysis using the societal perspective, but it was more effective and less costly (dominant) among participants with more severe OUD, or those whose current treatment episode was longer than 28 days. Further trials are needed to evaluate if BUP-XR is associated with better clinical and health economic outcomes over the longer term. Indivior.

Purpose: (i) Characterize ultra-processed food (UPF) intakes in toddlerhood and mid-childhood, including identifying principal UPF sub-groups and associations with nutrient profile; (ii) explore stability and change in UPF intake between toddlerhood and mid-childhood. Methods: Data were from children in the UK Gemini twin cohort at 21 months (n = 2,591) and 7 years (n = 592) of age. UPF intakes were estimated using diet diaries and Nova classification. Complex samples general linear or logistic regression models were used to explore associations between UPF intake, UPF sub-groups and nutrients, and changes in intake over time. Results: The contribution of UPF to total energy was 46.9% (± 14.7) at 21 months and 59.4% (± 12.5) at 7 years. Principal UPF sub-groups were yogurts, higher-fiber breakfast cereals, and wholegrain breads in toddlerhood, and puddings and sweet cereal products and white breads in mid-childhood. At both ages, mean free sugar and sodium intakes exceeded recommended maximums and higher UPF consumption was associated with consuming more of each nutrient (P < 0.001). UPF intake was negatively associated with fat, saturated fat and protein intake in toddlerhood, and fiber intake in mid-childhood (P < 0.001). Being in the highest UPF intake quintile in toddlerhood was predictive of being in the highest quintile in mid-childhood (OR 9.40, 95%CI 3.94–22.46). Conclusions: UPF accounted for nearly half of toddlers’ energy, increasing to 59% in mid-childhood. Higher UPF consumers had higher intakes of free sugar and sodium. UPF intake in toddlerhood was predictive of mid-childhood intake. Effective policies are needed to reduce UPF intakes in the early years.

Objectives During the COVID-19 pandemic, addiction treatment services received official guidance asking them to limit face-to-face contact with patients and to prescribe opioid agonist treatment (OAT) medication flexibly. With the aim for most patients to receive take-home supplies for self-administration rather than attendance for observed daily dosing. Design This was a theory-driven, clinically applied qualitative study, with data for thematic analysis collected by semi-structured, audio-recorded, telephone interviews. Participants Twenty-seven adults (aged ≥18 years) enrolled in sublingual (tablet) buprenorphine and oral (liquid) methadone OAT. Setting Community addictions centre in the London Borough of Lambeth operated by South London and Maudsley NHS Trust. Results Three major themes were identified: (1) dissatisfaction and perceived stigma with OAT medication dispensing arrangements before the pandemic; (2) positive adaptations in response to COVID-19 by services; (3) participants recommended that, according to preference and evidence of adherence, OAT should be personalised to offer increasing medication supplies for self-administration from as early as 7 days after commencement of maintenance prescribing. Conclusions In an applied qualitative study of patients enrolled in OAT during the COVID-19 pandemic, participants endorsed their opportunity to take medication themselves at home and with virtual addiction support. Most patients described a preference for self-administration with increased dispensing supplies, from as early as 7 days into maintenance treatment, if they could demonstrate adherence to their prescription.

Mental imagery manipulations are used to treat several psychological disorders, but their utility in treating cocaine use disorder (CUD) is unknown. Using prompted re‐experiences and simulations with contrasting valence, we assessed the acute impact of a deliberate mental imagery task on cocaine craving.Design: A quantitative–qualitative ‘mixed‐methods’ analysis of data collected for a randomized controlled trial that was stopped prematurely.Setting: UK National Health Service addictions treatment clinic and outpatient clinical research facility (laboratory).Participants: Adults with CUD. The original target sample was 120. All participants enrolled at the point the original trial was stopped were included (38 enrolled, 31 completed study).Interventions: Personalized (3‐minute) cue–exposure (handling cocaine paraphernalia and watching video of drug preparation), immediately followed by a single 5‐minute, audio‐recorded, self‐guided and verbally described imagery task with random assignment to one of four conditions: two mental imagery memory re‐experiences (positive image before initiation to cocaine use or a negative image of a ‘worst time’ adverse cocaine use episode) or two future simulations (positive theme of recovery from CUD or negative theme of worsened CUD).Measurements: Task transcripts were rated for imagery detail using five dimensions using a six‐point scale of imagery detail (ID) (total score = 0–25) and thematically coded. The outcome measure was cocaine craving using the Craving Experiences Questionnaire—strengths version (CEQ–S11; score = 0–110) reported at baseline, arrival at the laboratory, and immediately after the cue–exposure and mental imagery tasks.Findings: A mixed‐effects, longitudinal, restricted linear regression, with the past‐positive imagery condition as referent, showed main effects of reduced craving after the imagery task (b = –29.2, 95% confidence interval (CI) = –45.3 to −13.1, P‐value < 0.001) and increased craving for the future‐negative task (b = 14.2, 95% CI = 0.1–28.4, P‐value 0.049). There was a future‐negative task by post‐imagery craving interaction (b = 28.1, 95% CI = 0.1–56.1, P‐value 0.049). A theory‐driven, deductive/inductive qualitative analysis of the transcripts revealed six major themes: sensory characteristics, CUD vicious cycle, self‐care, emotions and appraisals, social role and CUD recovery. Positively themed simulations included interpersonal connections and rewarding activity; negative images included personal adversity, with appraisals of self‐criticism and hopelessness. Transcripts with more imagery detail were not associated with significantly greater reductions in craving in the positive or negative imagery task (r = –0.32, 95% CI = –0.69 to 0.13 and r = 0.06, 95% CI = –0.58 to 0.53, respectively).Conclusion: In people with cocaine use disorder, after cue–exposure, a self‐guided imagery task with positive themes reduced craving, whereas mental imagery simulating worsened cocaine use disorder did not appear to.

Objectives Opioid agonist, partial agonist and antagonist medications are used to treat opioid use disorder (OUD). This was the first omnibus narrative systematic review of the contemporary qualitative literature on patient experiences of receiving these medications. Design Narrative systematic review using the sample, phenomenon of interest, design, evaluation and research framework. Data sources PubMed, Embase and APA PsycINFO were searched between 1 January 2000 and 14 June 2023, with the addition of hand searches. Eligibility criteria for selecting studies Qualitative and mixed methods studies among adults with experience of receiving OUD treatment medication in community and criminal justice settings. Data extraction and synthesis One reviewer conducted searches using the pre-registered strategy. Two independent reviewers screened studies and assessed quality using the Consolidation Criteria for Reporting Qualitative tool. Identified reports were first categorised using domains from the addiction dimensions for assessment and personalised treatment (an instrument developed to guide OUD treatment planning), then by narrative synthesis. Results From 1129 studies, 47 reports (published between 2005 and 2023) were included. Five major themes (and nine subthemes) were identified: (1) expectations about initiating treatment (barriers to access; motivations to receive medication); (2) responses to medication induction and stabilisation; (3) experience of the dispensing pharmacy (attending; medication dispensing); (4) experiences of maintenance treatment (services; dose adjustment; personal and social functioning); and (5) social factors (integration and stigma) and experiences of discontinuing treatment. Together these themes reflected and endorsed the importance of patient-centred care and clinically integrated services. Further qualitative research in real-world settings is needed on extended-release buprenorphine given the relative novelty of this medication option. Conclusions A narrative systematic review of the qualitative studies of medications for OUD endorsed the importance of patient-centred care and clinically integrated services. PROSPERO registration number CRD42019139365.

Background and aims: An investigation of 24 weeks of extended‐release buprenorphine (BUP‐XR; Sublocade®) treatment for adults with opioid use disorder (OUD). Study aims were to characterise variations in clinical response, investigate personal factors influencing BUP‐XR experience and identify opportunities to tailor treatment interventions.Design: A convergent parallel mixed‐methods evaluation embedded in a five‐centre, phase 3, randomised controlled trial of BUP‐XR versus daily oral methadone or sublingual buprenorphine.Setting: Four of five National Health Service addictions treatment clinics in England and Scotland from the trial.Participants: Participants were recruited after they completed the 24‐week endpoint. Forty‐nine participants (31%) from the trial completed the qualitative interview.Measurements: Three outcome measures from the trial's dataset were used descriptively: (1) fortnightly clinic visit administered TimeLine Follow‐Back interview and urine drug screen data on use of non‐medical opioids, cocaine and benzodiazepines; (2) the frequency version of the 11‐item Craving Experience Questionnaire administered at baseline and endpoint; and (3) the Structured Clinical Interview for DSM‐5 disorders for diagnosis of early OUD and cocaine use disorder (CUD) remission. Data visualisation (by heatmap) identified drug use response sub‐groups. A topic‐guided, semi‐structured qualitative interview was analysed by Interactive Categorisation.Findings: Three response sub‐groups were identified: Group 1 [14 (28.5%) of 49 participants] had the highest level of response, characterised by continuous abstinence from opioids, cocaine and benzodiazepines, improvements in craving control and mental and physical health in the majority, and a high level of remission and satisfaction with care; Group 2 [14 (28.5%) of 49 participants] had the next level of response, characterised by continuous abstinence from opioids, but some with opioid craving and some with compensatory use of cocaine and benzodiazepine to cope with anxiety and stress; Group 3 [21 (43.0%) of 49 participants] were not continuously abstinent from opioids during follow‐up, the majority had dual OUD and CUD at trial enrolment, some reported breakthrough opioid withdrawal symptoms during follow‐up, the majority reported improvements in mental health, but many reported opioid and cocaine cravings and compensatory use of cocaine and benzodiazepines.Conclusions: There appears to be variation in response and experience of extended‐release buprenorphine during the first six months of treatment, depending on substance use and physical health. This highlights the need for tailored treatment plans based on differing individual needs.