Literature Collection

OBJECTIVE: To determine if men who have sex with men (MSM) with cocaine use disorder (CUD) and actively-using cocaine could be enrolled and retained in a pharmacologic intervention trial of lorcaserin-a novel 5-HT2cR agonist-and determine the degree to which participants would adhere to study procedures. METHODS: This was a phase II randomized, double-blind, placebo-controlled pilot study with 2:1 random parallel group assignment to daily extended-release oral lorcaserin 20 mg versus placebo (clinicaltrials.gov identifier-NCT03192995). Twenty-two of a planned 45 cisgender MSM with CUD were enrolled and had weekly follow-up visits during a 12-week treatment period, with substance use counseling, urine specimen collection, and completion of audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps and self-report. This study was terminated early because of an FDA safety alert for lorcaserin's long-term use. RESULTS: Eighty-six percent completed the trial, with 82% of weekly study follow-up visits completed. Adherence was 55.3% (lorcaserin 51.6% vs. placebo 66.2%) by MEMS cap and 56.9% (56.5% vs. placebo 57.9%) by self-report and did not differ significantly by treatment assignment. Intention-to-treat analyses (ITT) did not show differences in cocaine positivity by urine screen between the lorcaserin and placebo groups by 12 week follow-up (incidence risk ratio [IRR]: 0.96; 95%CI = 0.24-3.82, P = 0.95). However, self-reported cocaine use in timeline follow-back declined more significantly in the lorcaserin group compared to placebo (IRR: 0.66; 95%CI = 0.49-0.88; P = 0.004). CONCLUSION: We found that it is feasible, acceptable, and tolerable to conduct a placebo-controlled pharmacologic trial for MSM with CUD who are actively using cocaine. Lorcaserin was not associated with significant reductions in cocaine use by urine testing, but was associated with significant reductions in self-reported cocaine use. Future research may be needed to continue to explore the potential utility of 5-HT2cR agonists.

BACKGROUND: Patients with opioid use disorder (OUD) often have complex health care needs. Methadone is one of the medications for opioid use disorder (MOUD) used in the management of OUDs. Highly restrictive methadone treatment-which requires patient compliance with many rules of care-often results in low retention, especially if there is inadequate support from healthcare providers (HCPs). Nevertheless, HCPs should strive to offer patient-centred care (PCC) as it is deemed the gold standard to care. Such an approach can encourage patients to be actively involved in their care, ultimately increasing retention and yielding positive treatment outcomes. METHODS: In this secondary analysis, we aimed to explore how HCPs were applying the principles of PCC when caring for patients with OUD in a highly restrictive, biomedical and paternalistic setting. We applied Mead and Bower's PCC framework in the secondary analysis of 40 in-depth, semi-structured interviews with both HCPs and patients. RESULTS: We present how PCC's concepts of; (a) biopsychosocial perspective; (b) patient as a person; (c) sharing power and responsibility; (d) therapeutic alliance and (e) doctor as a person-are applied in a methadone treatment program. We identified both opportunities and barriers to providing PCC in these settings. CONCLUSION: In a highly restrictive methadone treatment program, full implementation of PCC is not possible. However, implementation of some aspects of PCC are possible to improve patient empowerment and engagement with care, possibly leading to increase in retention and better treatment outcomes.