Have clinically significant laboratory values (outside of normal limits).
#The outlast trials series trial#
Be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area, or any clinically significant mental or physical illness within a 1-year prior, that would impact compliance with trial requirements.Have positive saliva drug screens for psychoactive substances other than amphetamines at the screening visit.Be mandated by the court to obtain treatment for methamphetamine-dependence where such mandate required the results of methamphetamine testing to be reported to the court.Have a history of unstable cardiovascular disease that is not adequately controlled at the time of eligibility determination.Have a current diagnosis of anorexia nervosa or bulimia disorder.Have a history of allergic or environmental bronchial asthma within the past 3 years.Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications.Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other monoclonal antibodies, any inactive ingredient of IXT-m200, or any other products required for the study procedures.Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine).Mild severity dependence on alcohol or marijuana is allowed Have current dependence, defined by DSM-5 criteria, on any psychoactive substance (i.e., opioids or benzodiazepines), other than methamphetamine or nicotine (any severity).Successfully complete app-based training program as evidenced by completion of at least 75% of daily drug use surveys and assigned saliva drug screens (two of which must be valid) in ≤30 days from the screening visit during the screening period.Have access to a smartphone or other device capable of supporting the study app.Agree to adhere to Lifestyle Considerations throughout study duration.Agree to use protocol-specified method(s) of birth control throughout study participation.Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study.Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent.Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period.
#The outlast trials series manual#
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