Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 (NCT05034874) | Clinical Trial Compass
TerminatedPhase 2
Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200
Stopped: Interim analysis concluded planned study numbers combined with participant dropout rates were insufficient to meet primary endpoint.
United States61 participantsStarted 2022-06-09
Plain-language summary
This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).
Who can participate
Age range18 Years
SexALL
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Eligible participants will:
1. Be at least 18 years of age at the time of study consent;
2. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Substance Use Disorder associated with methamphetamine;
3. Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period;
4. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
5. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
6. Agree to use protocol-specified method(s) of birth control throughout study participation;
7. Agree to adhere to Lifestyle Considerations throughout study duration;
8. Have access to a smartphone or other device capable of supporting the study app;
9. 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.
Eligible participants will NOT:
1. Have current dependence, defined by DSM-5 criteria, on any psychoactive substance (i.e., opioids or benzodiazepines), other than methamphetamine or nicotine (any severity). Mild severity dependence on alcohol or marijuana is allowed;
2. Be currently taking certain other drugs and medications, including: "designer dru…
What they're measuring
1
Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period