A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorClear Scientific, Inc.
About this trial
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
Qualifiers
Healthy participants aged 18 to 55 years, inclusive;
Meets DSM-5 criteria for methamphetamine use disorder;
Not seeking treatment for methamphetamine use disorder;
Primary route of methamphetamine self-administration must be intravenous or smoking;
Disqualifiers
Estimated glomerular filtration rate <60 mL/min/1.73 m2;
History of cardiovascular disease;
Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Trial design
Treatments tested in this trial
- Methamphetamine
- Sterile Saline
- CS-1103
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Clear Scientific, Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov