Methamphetamine Intoxication, Methamphetamine Disorders, Methamphetamine Abuse
Conditions
Brief 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).
Interventions
DRUGMethamphetamine
Methamphetamine HCl for intravenous administration
DRUGSterile Saline
Sterile Saline for intravenous administration
DRUGCS-1103
CS-1103 for intravenous administration
Sponsors
National Institute on Drug Abuse (NIDA)
Clear Scientific, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations | 3 days plus follow-up on Day 10 | Physical examinations |
| Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs) | 3 days plus follow-up on Day 10 | Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted. |
| Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs | 3 days plus follow-up on Day 10 | Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature |
| Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters | 3 days plus follow-up on Day 10 | Clinical chemistry, hematology, coagulation, and urinalysis |
| Time course and magnitude of urine excretion of methamphetamine | 48 hours | Measurement of concentration of methamphetamine in urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time course of CS-1103 blood and urine concentrations | 48 hours | Measurement of plasma and urine concentrations of CS-1103 |
Countries
United States
Contacts
Primary ContactAnna Del Rosario, B.S.
Backup ContactPiercen Oliver, Ph.D.
Outcome results
None listed