Testing LDX-01 plus TAU against a placebo for methamphetamine abuse

Exclusion

• −Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; confirmed current hyperthyroidism; known hypersensitivity or idiosyncrasy to the sympathomimetic amines or glaucoma or any disabling, severe, or unstable medical condition (including electrolyte disturbances) that, in the opinion of the study physician, precludes safe participation or the ability to provide fully informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
• −History of a SAESerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more →, hypersensitivity or known allergic reaction to LDX-01 or other amphetamine drugs, or hypersensitivity to the sympathomimetic amines;
• −Any severe or unstable co-morbid substance use disorder that, in the opinion of the study physician, precludes safe participation in the study;
• −Participants with Opioid Use Disorder (OUD) who have been on Opioid Agonist Treatment (OAT) for \<12 weeks, and not yet at stabilization dose, or at stabilization dose \<4 weeks;
• −Current or a history of any serious psychiatric disorder (e.g., bipolar disorder, pre-existing psychosis, schizophrenia) that, in the opinion of the study physician, precludes safe participation in the study;
• −Use of an investigational drug for stimulant use disorder during the 30 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, confirmed via self-report or pharmacy records; excluding the use of study medication in the parent ASCME trial;
• −Use of prescribed amphetamine-type medication or medication for the treatment of stimulant use disorder (e.g., methylphenidate, modafinil, bupropion, or mirtazapine) in the 4 weeks before screening;
• −Current or anticipated need for treatment with any medication that may interact with LDX-01 (e.g., monoamine oxidase inhibitors \[MAOIs\]) used currently or within the past 14 days and that would preclude study participant at the discretion of the study physician;
• −ECG measurement (Bazett method for the correction of QT interval) that indicates a prolonged QTc interval (≥460 milliseconds for females and ≥450 milliseconds for males) at screening;
• −Any SAEs related to the study product in the parent trial phase that, in the opinion of the study physician, precludes safe participation in the extension study;
• −Any compliance issues related to the study product and/or study procedures during the parent trial phase that, in the opinion of the study physician, precludes safe participation in the extension study.
• −Pregnant, nursing, or planning to become pregnant during the study period;
• −Planned extended absence during the study period (e.g., pending legal action, surgery, incarceration, inpatient residential program) in the opinion of the study physician that might prevent completion of the study;