A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methamphetamine, Sterile Saline, CS-1103.
- Who it may be relevant to
- Registry conditions: Methamphetamine Intoxication, Methamphetamine Disorders, Methamphetamine Abuse. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants With Methamphetamine Use Disorder Not Seeking Treatment Receiving a Single Dose of Methamphetamine
Overview
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
- Drug Methamphetamine
Methamphetamine HCl for intravenous administration - Drug Sterile Saline
Sterile Saline for intravenous administration - Drug CS-1103
CS-1103 for intravenous administration
Primary outcome measures
- Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations [Time frame: 3 days plus follow-up on Day 10]
- Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs) [Time frame: 3 days plus follow-up on Day 10]
- Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs [Time frame: 3 days plus follow-up on Day 10]
- Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters [Time frame: 3 days plus follow-up on Day 10]
- Time course and magnitude of urine excretion of methamphetamine [Time frame: 48 hours]
Secondary outcome measures (1)
- Time course of CS-1103 blood and urine concentrations [Time frame: 48 hours]
Eligibility criteria
Major Inclusion Criteria:
- 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;
- Able to abstain from methamphetamine without experiencing severe withdrawal;
- A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 56 kg;
- Females must not be lactating and must have a negative pregnancy test during screening and admission.
Major Exclusion Criteria:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- California Clinical Trials Medical Group — Glendale
Identifiers
NCT: NCT06721494 · CS-1103-02 · 5U01DA058548-02