A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Clear Scientific, Inc. · with National Institute on Drug Abuse (NIDA) · NCT06721494
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–55 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- February 5, 2026
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Methamphetamine; Sterile Saline; CS-1103
Conditions: Methamphetamine Intoxication; Methamphetamine Disorders; Methamphetamine Abuse
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
California Clinical Trials Medical Group
Glendale, CA 91206
Site contact: Lev Gertsik, M.D. · 888-228-7425 · study.losangeles@parexel.com
Study contacts (from the official record)
- Anna Del Rosario, B.S. · 617-621-8500 · adelrosario@clearsci.com
- Piercen Oliver, Ph.D. · 617-621-8500 · poliver@clearsci.com