Health TrialsbyHealthPanel

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

ConditionsMethamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Methamphetamine

    Drug

    Methamphetamine HCl for intravenous administration

  • Sterile Saline

    Drug

    Sterile Saline for intravenous administration

  • CS-1103

    Drug

    CS-1103 for intravenous administration

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 2 interventions
Group B: ActiveActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations

Physical examinations

Time frame
3 days plus follow-up on Day 10
2

Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)

Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted.

Time frame
3 days plus follow-up on Day 10
3

Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs

Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature

Time frame
3 days plus follow-up on Day 10
4

Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters

Clinical chemistry, hematology, coagulation, and urinalysis

Time frame
3 days plus follow-up on Day 10

Secondary outcomes

1

Time course of CS-1103 blood and urine concentrations

Measurement of plasma and urine concentrations of CS-1103

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clear Scientific, Inc.

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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