Covid and the lima study, a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence

Abstract

Introduction/Issues:The LiMA study is a randomised, double-blind, placebo-controlled trial of lisdexamfetamine for the treatmentof methamphetamine dependence. Thefirst participant was random-ised in May 2018. The COVID-19 pandemic required adaptation totrial procedures from March 2020.Method/Approach:A COVID-19 plan was established for allfivesites and the study protocol was amended to allow for up to14 unsupervised take-away doses, a decrease in face-to-face visitsfrom twice weekly to weekly, and increase in use of telephoneassessments.Key Findings:No participant was recruited between 12 March and15 November 2020. Participants enrolled in the study prior to12 March 2020 were able to remain in the study, althoughfive of the22 participants (23%) in the active study medication phase withdrewduring this period. Recruitment recommenced at four out offivesites from 16 November 2020. Prior to 12 March 2020, 117 partici-pants were randomised to the trial and received at least one dose ofstudy medication (five participants per month) and 28 participantsbetween 16 November 2020 and 21 June 2021 (four per month).Discussion and Conclusions:The COVID-19 pandemic period inAustralia resulted in relaxation of the strictly supervised proceduresby necessity. Adapted methods facilitated retention and enabledongoing recruitment post-the initial shut down period. Findings haverelevance for intensity of supervision in study procedures going for-ward. Results are anticipated early 2022.Implications for Practice or Policy:Findings from this“naturalexperiment”into altered study procedures in response to theCOVID-19 pandemic may have implications for supervisory require-ments of medication for the treatment and research of methamphet-amine dependence. Disclosure of Interest Statement:This research was funded bythe Australian National Health and Medical Research Council(Project Grant No. 1109466). NE has grants from the Australiangovernment Department of Health. AJD has research and travelsupport from Braeburn/Camurus, research support from Indiviorand has served on an advisory board for Mundipharma. RB hasreceived investigator-initiated untied educational grants from Rec-kitt Benckiser/Indivior. AC has received research funding fromBristol-Myers Squibb, Gilead Sciences, and ViiV Healthcare; lec-ture and travel sponsorships from Gilead Sciences and ViiVHealthcare; and has served on advisory boards for Gilead Sciences,MSD and ViiV Healthcare. MF has grants from the Australian Fed-eral Government Department of Health National Centre CoreFunding, untied grant from Indivior, and grants from SeqirusUnited. DIL has provided consultancy advice to Lundbeck andIndivior and has received travel support and speaker honoraria fromAstra Zeneca, Camurus, Indivior, Janssen, Lundbeck, Servier andShire. NL has received research funding from Camurus, and hasserved on Advisory Boards for Mundipharma, Camurus and Indi-vior. AG, CR, MM, MMcD, JW, KH, PH, RA, RG, RM and WLhave no interests to declare.