A study protocol for an open-label trial of oral lisdexamfetamine for the treatment of acute methamphetamine withdrawal (the OLAM study)
Presenter: Liam Acheson
Author names: 1,2Acheson, LS; 1,2,3,4Ezard, N; 4,5,6Dunlop, A; 4,7,8Lintzeris, N; 2,9Brett, J; 1Farrell, M; 1McKetin, R; 2Rodgers, C; 2Gill, A; 10Christmass, M; 11Shoptaw, S; 1,2,3Siefried KJ
Author affiliations: 1National Drug and Alcohol Research Centre, UNSW, Sydney Australia
2St Vincent’s Hospital, Sydney Australia
3National Centre for Clinical Research on Emerging Drugs, c/o UNSW, Sydney Australia
4Drug and Alcohol Clinical Research and Improvement Network, NSW Australia
5Hunter New England Local Health District, Newcastle Australia
6The University of Newcastle, Newcastle Australia
7South East Sydney Local Health District, Sydney Australia
8The University of Sydney, Sydney Australia
9Centre for Big Data Research in Health, UNSW, Sydney Australia
10Next Step Drug and Alcohol Services, Perth Australia
11Department of Family Medicine, University of California, Los Angeles USA
Introduction: There is currently no evidence-based treatment for methamphetamine (MA) withdrawal. Ineffective treatment of withdrawal symptoms likely contributes to poor engagement in treatment and high rates of relapse, and supporting withdrawal from MA can be the first step in a treatment journey. Lisdexamfetamine (LDX) is a promising candidate pharmacotherapy, with the potential to attenuate withdrawal symptoms and craving, and facilitate retention in care. This is the first study to investigate LDX for the management of acute MA withdrawal.
Aims: The primary outcome is to determine safety (biological parameters and adverse events) and feasibility (ability to recruit participants). Secondary outcomes are acceptability (Treatment Satisfaction Questionnaire for Medication, adherence, adjunctive symptomatic medications, and qualitative interviews), retention (to Day 5), withdrawal severity (Amphetamine Withdrawal Questionnaire, cravings by Visual Analogue Scale) and sleep measures (Consensus Sleep Diary, continuous actigraphy).
Methods: Fifteen adults with MA use disorder presenting to an inpatient unit for acute withdrawal management will be recruited to participate in an open-label, single-arm clinical trial. Participants will receive a tapering dose regimen of LDX: 250mg Day 1 reducing by 50mg per day until 50mg on Day 5, alongside treatment as usual withdrawal management. Participants will remain in the inpatient setting until Day 7 to monitor for adverse events and ensure they are stimulant free upon discharge. Telephone follow-up will be conducted on Days 14, 21 and 28.
Results: Recruitment and enrollment is brisk. Three participants are currently enrolled in the study, with another four booked for admission. The first two participants were retained through all 7 days, and successfully reached for follow up for each of three weeks post discharge.
Implications: This is the first study to investigate LDX for the treatment of acute MA withdrawal symptoms, and the first to examine sleep using objective measures in this population or context. If LDX is safe and feasible, then these results will be used to develop a fully powered RCT to investigate efficacy in this population.