RESUMO
BACKGROUND AND OBJECTIVES: Patients with opioid use disorder may be asked by their clinicians to discontinue maintenance buprenorphine treatment before surgical operations due to concerns that buprenorphine will interfere with acute pain management. However, discontinuation of buprenorphine may not be well tolerated or safe for all patients. We, therefore, administered a survey to better understand the experiences of patients on buprenorphine treatment who had previously undergone painful procedures and had their buprenorphine maintenance treatment either continued or discontinued before the procedure. METHODS: After this study received institutional review board approval, patients were invited to participate if they were being prescribed sublingual buprenorphine for treatment of opioid use disorder and had also previously undergone a painful procedure requiring treatment with full agonist opioids. Patients who were eligible and agreed to participate (n = 32) then completed a survey of basic demographics; medical, psychiatric, and substance use histories; and their experience and satisfaction with the treatment of pain and substance use in the perioperative period, including whether buprenorphine was continued or discontinued before their procedure. RESULTS: Compared with patients whose home dose of buprenorphine was continued (n = 15), patients whose buprenorphine was discontinued preoperatively (n = 17) reported less satisfaction with pain management and were more likely to be prescribed full agonist opioids upon discharge. DISCUSSION AND CONCLUSIONS: Consistent with prior studies, these survey findings suggest that discontinuation of buprenorphine before painful surgeries may be associated with poorer clinical outcomes. SCIENTIFIC SIGNIFICANCE: This survey study adds patients' perspective to a growing body of scientific literature suggesting that discontinuation of maintenance buprenorphine treatment before painful procedures may decrease patient satisfaction and increase clinical risk.
Assuntos
Buprenorfina , Transtornos Relacionados ao Uso de Opioides , Humanos , Buprenorfina/uso terapêutico , Analgésicos Opioides/uso terapêutico , Dor/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Combinação Buprenorfina e Naloxona/uso terapêuticoRESUMO
OBJECTIVE: Medication nonadherence is a serious issue in clinical trials, especially in studies of substance abuse disorders. Measuring and confirming adherence is critical to ensuring that collected data is accurate and interpretable. This study evaluated the feasibility and success of a smartphone-based approach (Cellphone Assisted Remote Observation of Medication Adherence [CAROMA]) to visually confirm medication adherence in a clinical trial. METHOD: Medication adherence was confirmed visually via smartphones provided to participants in a double-blind, randomized, placebo-controlled trial for cannabis dependence. Every morning, subjects (n=20) were video-called by staff who observed consumption of study medication. Adherence was also assessed with weekly face-to-face visits, pill counts and plasma drug levels. Subjects were paid for completing daily CAROMA visits, and for returning the smartphone at study completion. RESULTS: CAROMA confirmed 96.04% adherence to medication. Concordance between expected and actual remaining study medication counted at weekly study visits was 87.69%. Subjects assigned to active study medication had detectable plasma drug levels, while those assigned to placebo did not. CAROMA was estimated to cost approximately $100 per subject per week - a total of $300.24 per subject for the 3-week outpatient portion of the trial. CONCLUSION: This pilot study demonstrates the feasibility, success and cost-effectiveness of CAROMA to facilitate and confirm medication adherence in a clinical trial. Preliminary findings support larger and longer studies, and possibly applying this approach to clinical care - especially in other populations with high rates of medication nonadherence.