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Repurposing semaglutide as an adjunctive treatment for cocaine use disorder: protocol for a randomised controlled trial

Por: Yammine · L. · Versace · F. · Green · C. E. · Webber · H. E. · Yoon · J. H. · Gutierrez · A. D. · Leonard · S. J. · Weaver · M. F. · Schmitz · J.
Introduction

Cocaine use disorder (CUD) is a significant public health concern in the USA, with considerable prevalence and mortality and no Food and Drug Administration (FDA)-approved pharmacotherapies. Recent advances in addiction science emphasise the need for novel, mechanism-based treatments. Glucagon-like peptide-1 receptor agonists, such as semaglutide, have shown promise in modulating reward-related behaviours and may offer therapeutic benefits for CUD. We present a study protocol evaluating semaglutide, as an adjunct to cognitive behavioural therapy (CBT), as a novel approach for treating CUD.

Methods and analysis

This is a randomised, double-blind, placebo-controlled trial enrolling 75 treatment-seeking adults with CUD. Participants will be randomised 1:1 to receive either once-weekly semaglutide (0.25–1.0 mg) or placebo injections over 14 weeks, alongside weekly individual CBT. Primary outcomes include changes in neurophysiological reactivity to drug-related and non-drug-related motivationally relevant cues (late positive potential), behavioural economics (cocaine demand), craving (Cocaine Craving Questionnaire) and cocaine use (self-report, urine drug screens). Exploratory aims assess associations between mechanistic changes and cocaine use, consumption of other substances (ie, tobacco, alcohol and cannabis) and dose–response relationships. Data will be analysed using Bayesian statistical methods using an intention-to-treat approach.

Ethics and dissemination

The study has been approved by the UTHealth Committee for the Protection of Human Subjects (HSC-MS-25-0412) and is registered on ClinicalTrials.gov. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications and scientific conferences.

Trial registration number

NCT07227948.

Measuring and monitoring safety of older adults living in retirement homes: a scoping review protocol

Por: Backman · C. · Engel · F. D. · Tonjock Kolle · A. · Papp · R. · Lam · A. · Freeman · L. · Li · W. · Sterling · E. · Fung · S. G. · Sinha · S. K. · Manis · D. R. · Wang · T.-F. · Kehoe MacLeod · K. · Hecimovich · C. · Webber · C. · Maskerine · C. · Syrowatka · A. · Fancott · C. · Kobewka · D
Background

The global population of older adults has grown at an unprecedented rate, and projections indicate that the number of older adults will continue to increase considerably in the coming decades. The clinical complexity of older adults living in retirement homes, also known as assisted living settings, is also increasing, and the regulations to ensure quality and safety standards in retirement homes are highly variable. The purpose of this scoping review is to map and summarise the methods used to monitor and measure the safety of older adults living in retirement homes, providing an overview of existing approaches and areas requiring further investigation.

Methods

This scoping review will follow the five stages of the Arksey and O’Malley scoping review process. We will report this review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A comprehensive search of four electronic databases (MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Web of Science Core Collection) will be performed, and reference lists of included articles will be searched. We will conduct a two-step screening process, data extraction and analysis of the included studies. We will include all primary study designs that report on safety measurement and monitoring of any type of harms. Relevant grey literature will also be identified. We will exclude studies that only report results from facilities providing 24-hour skilled nursing care or specialised care services, and those not published in English or French. This protocol is registered on the Open Science Framework (osf.io/8rheq).

Ethics and dissemination

No ethical approval is needed for the review, and we plan to present the results at research conferences and in a peer-reviewed article. Our findings may inform future research studies that seek to support and improve safety practices in retirement homes.

Tailored exercise management versus usual care for people aged 80 years or older with hip/knee osteoarthritis and comorbidities (TEMPO): multicentre feasibility randomised controlled trial in England

Por: Nicolson · P. J. A. · Holden · M. A. · Marian · I. · Saeedi · E. · Williamson · E. · Moylan · D. · Stone · M. · Hopewell · S. · Lamb · S. E. · TEMPO feasibility trial collaborators · Barker · Dickson · Price · Webber
Objective

To assess the feasibility of conducting a definitive randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a tailored exercise intervention compared with usual care for people aged 80 years and older with hip and/or knee osteoarthritis (OA) and comorbidities.

Design

Two-arm, parallel-design, multicentre, pragmatic, feasibility RCT.

Setting

Four National Health Service outpatient physiotherapy services across England.

Participants

Adults aged 80 years and over with clinical hip and/or knee OA and ≥1 comorbidity.

Interventions

Participants were randomised 1:1 via a central web-based system to be offered: (1) a 12-week tailored exercise programme or (2) usual care. Participants and outcome assessors were not blinded to treatment allocation.

Feasibility objectives

(1) Ability to screen and recruit participants; (2) retention of participants at 14-week follow-up; (3) intervention fidelity (proportion of participants who received ≥4 intervention sessions as per protocol) and (4) participant engagement (assessed by home exercise adherence).

Results

Between 12 May 2022 and 26 January 2023, 133 potential participants were screened, of whom 94 were eligible. The main reasons for ineligibility were symptoms not consistent with hip or knee OA (10/39, 25.6%) or already having had a physiotherapy appointment (8/39, 20.5%). 51 of 94 (54%) eligible participants were recruited. Participants had a mean age of 84 years (SD 3.5), 31 (60.8%) were female and 96.1% reported their ethnicity as White British (n=49/51). 45 of 51 participants (88%) provided outcome data at the 14-week follow-up time point. Four or more intervention sessions were attended by 13/25 (52%) participants. Home exercise log completion declined over time: 6/23 participants (26.1%) returned completed exercise logs for all 12 weeks. The median number of days home exercises were recorded each week was 5 (range 0–7).

Conclusions

This study demonstrated that a definitive trial would be feasible. Before proceeding, modifications to ensure recruitment of a diverse population and intervention fidelity should be addressed.

Trial registration number

ISRCTN75983430.

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