1. Participant experiences in a pilot study for methamphetamine withdrawal treatment: Implications for retention.
- Author
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Acheson LS, Clay S, McKetin R, Lintzeris N, Dunlop A, Brett J, Christmass M, Rodgers C, Shoptaw S, Farrell M, Ezard N, and Siefried KJ
- Subjects
- Humans, Male, Pilot Projects, Female, Adult, Middle Aged, Communication, Trust, Interviews as Topic, Clinical Trials as Topic, Methamphetamine administration & dosage, Methamphetamine adverse effects, Substance Withdrawal Syndrome drug therapy, Amphetamine-Related Disorders
- Abstract
Introduction: There is little knowledge of the perspectives of people who use methamphetamine and have participated in clinical trials, and none for interventions not intended to address abstinence. A better understanding of these experiences could lead to more patient centred clinical trial design. This study seeks to understand the experiences of people who completed a clinical trial of lisdexamfetamine for the treatment of acute methamphetamine withdrawal., Methods: Thematic analysis of open-ended, semi-structured interviews with eight people who participated in an inpatient clinical trial of lisdexamfetamine for acute methamphetamine withdrawal. Interviews were conducted between days 3 and 6 of admission to an inner-city Sydney hospital., Results: Participants described how research procedures, the research setting, and the investigational product affected their experiences while enrolled in a clinical trial. Of particular importance to participants were transparent and low burden trial procedures, a welcoming trial environment, trusting relationships and effective communication, which were linked with the participants' subsequent decision to remain enrolled in the trial., Discussion: The experiences of participants in this clinical trial can be distilled into four meta-themes: agency, caring-trust, safety, and communication. Participants spontaneously linked these experiences with a capacity to remain enrolled in the study. By considering the experiences of trial participants in clinical trial design, researchers can improve the experiences of future trial participants and facilitate their choice to remain enrolled in clinical trials., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: LSA is supported by an NDARC PhD Scholarship. MF has received unrestricted funding for research purposes from Indivior and Sequiiris. SS has received clinical research supplies from Alkermes. NE and KJS are employed by NCCRED. No other investigators have any conflicts of interest to declare., (Copyright © 2024. Published by Elsevier B.V.)
- Published
- 2024
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