Randomised clinical trial of a 16 mg vs 24 mg maintenance daily dose of buprenorphine to increase retention in treatment among people with an opioid use disorder in Rhode Island: study protocol paper

Introduction
Buprenorphine is a highly effective treatment for opioid use disorder (OUD). However, provider observations and preliminary research suggest that the current standard maintenance dose may be insufficient for suppressing withdrawal and preventing cravings among people who use or have used fentanyl. Buprenorphine dosing guidelines were based on studies among people who use heroin and have not been formally re-evaluated since fentanyl became predominant in the unregulated drug supply. We aim to compare the effectiveness of a high (24 mg) vs standard (16 mg) maintenance daily dose of buprenorphine for improving retention in treatment, decreasing the use of non-prescribed opioids, preventing cravings and reducing opioid overdose risk in patients.

Methods and analysis
Adults who are initiating or continuing buprenorphine for moderate to severe OUD and have a recent history of fentanyl use (n=250) will be recruited at four outpatient substance use treatment clinics in Rhode Island. Patients continuing buprenorphine must be on doses of 16 mg or less and have ongoing fentanyl use to be eligible. Participants will be randomly assigned 1:1 to receive either a high (24 mg) or standard (16 mg) maintenance daily dose, each with usual care, and followed for 12 months to evaluate outcomes. Providers will determine the buprenorphine initiation strategy, with the requirement that participants reach the study maintenance dose within 7 days of randomisation. Providers may adjust the maintenance dose, if clinically needed, for participant safety. The primary study outcome is retention in buprenorphine treatment at 6 months postrandomisation, measured using clinical and statewide administrative data. Other outcomes include non-prescribed opioid use and opioid cravings (secondary), as well as non-fatal or fatal opioid overdose (exploratory).

Ethics and dissemination
This protocol was approved by the Brown Institutional Review Board (STUDY00000075). Results will be presented at conferences and published in peer-reviewed journals.

Trial registration number
NCT06316830.

Leggi
Novembre 2024

Effects of dim-evening lighting optimised for geographical orientation versus standard lighting on mental health: protocol paper for a quasiexperimental study in a psychiatric hospital

Introduction
Research has provided novel insights into how light stimulates circadian rhythms through specialised retinal ganglion cells to the suprachiasmatic nucleus. In addition, there has been a revolution in light-emitting diode (LED) technology, leading to tunable LED light sources and lighting systems, enabling 24-hour dynamic light scenarios with bright blue-enriched short wavelength light during the day and dim evening light, stimulating the circadian system. These dynamic LED lighting systems are now being implemented at hospitals without adequate understanding of how it may affect the health and well-being of patients and staff.

Methods and analysis
An optimised dynamic LED lighting scenario is investigated at a newly built psychiatric hospital in Copenhagen. In the 12 months baseline period, a standard lighting scenario with dynamic colour temperature and fixed light intensity is investigated. In the following 12-month intervention period, a new DEL scenario is investigated, having dynamic colour temperature as well as dynamic light intensity with a higher daytime and lower evening-time melanopic daylight equivalent illuminance. This setting is furthermore adjusted for geographical orientation to compensate for differences in sunlight access in wintertime. The study uses a quasiexperimental design comparing patients admitted in the two study periods. Prior to each of the study periods, daylight and the contribution from the LED-lighting scenarios was measured. Patient sociodemographic and mental health data will be retrieved retrospectively from electronic medical records and by questionnaires administered in the two periods, evaluating lighting, noise, sleep quality and quality of life. Primary outcome is the proportion of patients receiving pro re nata medications. Secondary outcomes are the length of stay, sleep onset latency, sleep quality and quality of life.

Ethics and dissemination
No ethical issues are expected. The results will be disseminated through peer-reviewed international journal, lectures, posters and interviews.

Trial registration number
NCT05868291.

Leggi
Ottobre 2024