A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine

Launched by CLEAR SCIENTIFIC, INC. · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called CS-1103 to see how safe and effective it is for people who use methamphetamine. The trial will involve giving participants a single dose of CS-1103 through an intravenous (IV) infusion while they are also receiving a standard dose of methamphetamine. The goal is to find out how well the medication works and how it behaves in the body.

To participate, individuals must be healthy, aged between 18 and 55, and diagnosed with methamphetamine use disorder but not currently seeking treatment. They should primarily use methamphetamine by injecting or smoking it and must be able to avoid using it for the study without severe withdrawal symptoms. Participants will need to meet certain health criteria, and there are some health conditions that would exclude someone from participating to ensure their safety during the trial. It's important to note that this study is not yet recruiting participants, so there is still time to learn more before deciding to join.

Gender

ALL

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 50 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 \<60 mL/min/1.73 m2;
• • 2. History of cardiovascular disease;
• • 3. Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
• • 4. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.