Evaluating the feasibility of prolonged-release buprenorphine formulations as an alternative to daily opioid agonist therapy regardless of prior treatment adherence: a pilot study.

BACKGROUND: Effective opioid agonist therapy (OAT) depends on good patient adherence. However, the daily, supervised administration of standard OAT represents a significant burden to patients and often drives poor adherence. Prolonged-release buprenorphine (PRB) formulations may mitigate some of this burden, enabling clinic visits to be substantially reduced. For treatment guidelines to be effective, the likely benefit of a transition to PRB therapy in different patient populations must be established. METHODS: The aim was to determine the feasibility of assessing PRB as an alternative to daily OAT in two groups: those currently adhering well to daily OAT (group 1, N = 5) and those not currently showing adherence or a positive response to daily OAT (group 2, N = 10). This open-label, prospective, non-controlled pilot study was conducted at the Kaleidoscope Drug Project in South Wales, UK. Participants were assessed for history, drug use, psychosocial assessment scores, and clinical severity at baseline and after 6 months of treatment. Primary outcomes were the feasibility of assessing PRB as an alternative to daily OAT and the acceptability of PRB therapy in each group. Secondary outcomes were treatment response, on-top drug use, psychosocial measures, and assessment of clinical severity. RESULTS: Participants from both groups demonstrated high levels of participation with assessment protocols at both baseline and 6-month follow-up, indicating study feasibility. PRB treatment was acceptable to the majority of participants, with all of group 1 and 70% of group 2 adhering to PRB therapy for the duration of the study and opting to persist with PRB therapy over other OAT options after study completion. All participants who remained on treatment demonstrated marked improvements in psychosocial and clinical severity assessment scores, with some returning to employment or education. On-top drug use remained absent in group 1 and was reduced in group 2. CONCLUSIONS: Evaluation of transition of participants from daily OAT to PRB therapy was shown to be feasible, acceptable, and effective across both groups. A larger randomised controlled trial is warranted, particularly to assess PRB therapy in participants with a history of poor treatment engagement, as the need for therapy is greater in this group and their management is associated with higher costs of care.

Increased Treatment Engagement and Adherence: Flexible Management with Prolonged-Release Buprenorphine in Treatment of Opioid Dependence.

Opioid dependence (OD) is effectively treated with well-evidenced regimens including psychosocial and opioid agonist pharmacotherapy. Many do not engage with treatment services; reasons include the burden of mandatory supervision and stigma. Injectable prolonged-release buprenorphine (PRB) offers choice and flexibility in treatment. Experience reported here demonstrates the potential for PRB to enable wider engagement with treatment services. Treatment was successful in patients unable to attend daily observed therapy due to work commitments, unable to use services for fear of stigma, or having not achieved goals on previous attempts with conventional approaches. PRB therapy was clinically successful without withdrawal signs or evidence of use of other drugs. Patient-reported outcomes were positive including maintained ability to work, manageable detoxification experience, and stigma-free treatment. This work provides evidence of PRB benefit in expanding treatment engagement.

Patient-Reported Outcomes, Experiences and Satisfaction with Weekly and Monthly Injectable Prolonged-Release Buprenorphine.

INTRODUCTION: Prolonged-release buprenorphine (PRB), administered by weekly or monthly injection, for opioid dependence (OD) treatment offers the potential to address some limitations of oral therapy including stigma, difficulty in achieving consistent appropriate dosing, risk of diversion of medications, risk of overdose, and continuing use of other drugs. Patient-reported outcomes (PRO) and experiences are important in the evaluation of OD therapy success. This work aimed to document PRO during PRB therapy to guide future treatment decision-making. METHODS: Qualitative interviews were completed with people on PRB OD treatment. Twenty individuals from four treatment services in England and Wales were asked to participate. A structured interview was developed guided by a person with OD lived experience. Interviews were transcribed, coded and analyzed using iterative categorization. RESULTS: Fifteen of 20 individuals approached agreed to participate, and 14 completed interviews. The average age of participants was 42 (range 33-54) years, 13 males and 1 woman, the history of problematic opioid use was 14 years (3-25 years), time in treatment was 7 years (1-20 years), and duration on treatment with PRB was 4 months (range 1-8 months). Participants reported treatment experiences leading to coding of 277 unique comments: therapy effectiveness (77% indicated a benefit of, or satisfaction with, PRB therapy, 7% neutral/general, 16% indicated concern or questions about PRB therapy), convenience (81% benefit, 7% neutral/general, 12% concern), and overall satisfaction (81% benefit, 3% neutral/general, 16% concern). Reported benefits include cravings reduction of 10 (71%), self-care improvement of 10 (71%), relationships improvement of 9 (64%), resources management of 6 (43%), positive outlook on life of 12 (86%). Participants reported a range of positive personal experiences; challenges reported included temporary injection discomfort at treatment initiation. DISCUSSION: In this small, focused population, there was generally a positive level of treatment satisfaction with PRB. These experiences provide insights to explain potential treatment benefit to others and are useful in guiding therapy choices for others in the future.

Management of opioid painkiller dependence in primary care: ongoing recovery with buprenorphine/naloxone.

Opioid painkiller dependence is a growing problem and best-practice management is not well defined. We report a case of a young woman exhibiting dependence on codeine, originally prescribed for myalgic encephalopathy, after escalating use over a 10-year period. In 2012, a consultation with a new general practitioner, who had extensive experience of patients with substance abuse, revealed the underlying dependence. After building trust for 6 months, she was able to admit to medication abuse, and was referred to the community drug and alcohol team. On presentation to the team, the patient had no pain issues and the dihydrocodeine use--600 tablets/week--solely reflected her dependence. The patient successfully underwent rapid induction with buprenorphine/naloxone as opioid substitution treatment over 2 days. She is currently stable, engaged with recovery support services and psychosocial counselling, and has just returned to work. She is maintained on a therapeutic dose of buprenorphine 10 mg/naloxone 2.5 mg.