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NCT06721494
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Conditions: Methamphetamine Intoxication, Methamphetamine Disorders, Methamphetamine Abuse
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Clear Scientific, Inc.
Location: California Clinical Trials Medical Group Glendale California
Summary
The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).
Eligibility Criteria
Major Inclusion Criteria:
1. Healthy participants aged 18 to 55 years, inclusive;
2. Meets DSM-5 criteria for methamphetamine use disorder;
3. Not seeking treatment for methamphetamine use disorder;
4. Primary route of methamphetamine self-administration must be intravenous or smoking;
5. Able to abstain from methamphetamine without experiencing severe withdrawal;
6. A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 56 kg;
7. Females must not be lactating and must have a negative pregnancy test during screening and admission.
Major Exclusion Criteria:
1. Estimated glomerular filtration rate \
Source: ClinicalTrials.gov (NCT06721494). StuddyBuddy aggregates publicly available trial information.
