Phenobarbital for the management of severe acute alcohol withdrawal (the PHENOMANAL trial): a pilot randomized controlled trial

Background Benzodiazepines are considered first-line treatment for patients experiencing severe acute alcohol withdrawal syndrome (sAAWS). Although several medications have been evaluated as potential adjuvant treatments for sAAWS, barbiturates show particular promise. Objective In the PHENOMANAL trial, we will assess the feasibility of conducting an allocation-concealed, quadruple-blinded, randomized controlled trial (RCT) comparing symptom-triggered benzodiazepine therapy with either a single dose of adjuvant intravenous (IV) phenobarbital (7.5 mg/kg of ideal body weight) or a single dose of matching IV placebo for patients with sAAWS. Methods We will recruit adult patients from the Emergency Department, Intensive Care Unit, or hospital wards with a Clinical Institute of Withdrawal – Adult revised (CIWA-Ar) score of 16 or more after receipt of at least 60 mg of diazepam or equivalent within 16 h of diagnosis of sAAWS, and an anticipated need for hospitalization. We will randomize participants (n=39) in a 2:1 manner to treatment and placebo groups, respectively. The primary objective of the PHENOMANAL pilot trial will be to demonstrate our ability to recruit the desired population over the trial period. As secondary objectives, we will evaluate clinician compliance with the treatment protocols, assess crossover rates from the placebo arm to the treatment arm, and obtain preliminary estimates of treatment effect. All trial participants will be followed for 7 days or until hospital discharge. Relevance The PHENOMANAL trial is novel in investigating a new treatment for a common and understudied condition, repurposing an existing medication for a novel indication, and addressing an important evidence gap. Through conduct of the multidisciplinary pilot trial, we aim to advance methodology in acute care research through the use of a hybrid consent model and inform the design of a large-scale trial. Trial registration ClinicalTrials.gov Registration NCT03586089 ; first registered July 13, 2018.Other UBCNon UBCReviewedFacultyOthe

The ART of conversation: feasibility and acceptability of a pilot peer intervention to help transition complex HIV-positive people from hospital to community

Objectives To pilot a peer-based intervention for people living with HIV who used substances, had challenges with antiretroviral adherence and would be discharged from hospital to community. Study design A community-based, quasi-experimental pilot intervention study designed to assess feasibility, acceptability and connection to a community-based HIV organisation. Setting This study was conducted in Toronto, Canada, at Casey House (CH; hospital for people living with HIV) in collaboration with the AIDS Committee of Toronto (ACT; community-based HIV organisation). Participants People living with HIV who were CH inpatient between 1 April 2017 and 31 March 2018, struggled with antiretroviral adherence, actively used substances and would be discharged to community were eligible. Forty people met criteria, 19 were approached by an inpatient nurse and 17 consented. Average age was 48.8 years (SD=11.4), 58.8% were male and participants averaged 7.8 physical and mental health comorbidities (SD=3.1). Intervention Titled 'The ART of Conversation', the threepronged personalised intervention was developed through input from CH clients and ACT volunteers, all living with HIV. Intervention components were (a) predischarge goalsetting (adherence, substance use and self-identified goal) with the study nurse; (b) predischarge meeting with an HIV+ peer volunteer (PV) and (c) nine postdischarge phone calls between PV and participant, once per day for 3 days, then once per week for 6 weeks. Primary outcomes Feasibility was measured through proportion of eligible participants recruited and PV availability. Acceptability was assessed through participant interviews at three times (preintervention, postintervention and 6 weeks follow-up) and through PV call logs. Client records determined connection to ACT within the study timeframe. Results Twelve participants completed the intervention and nine connected with ACT. Predischarge goal-setting and PV meeting were both feasible and acceptable. Postdischarge phone calls were a challenge as half of completers missed at least one call. Conclusions Although predischarge goal-setting and PV meeting were feasible, methods to maintain connection following discharge require further investigation.This work was funded by the Ontario HIV Treatment Network (OHTN) through a Community-Based Research and Evaluation Grant (Grant number CBRG1074), with additional support from Universities Without Walls and the Canadian Association for HIV Research through their Flipped Workshop Mentoring program. ADE is supported by an OHTN Endgame Leader Award. SLC is a Canada Research Chair. Disclaimer The funders did neither have a role in the design and conduct of the study, nor in the decision to submit the study for publication