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COMPLETED Phase 1

Phase1, STP7 Cocaine Drug-Drug Interaction Study

NCT06273540 · View on ClinicalTrials.gov ↗

Study Summary

This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age. The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval). The secondary objectives are: * To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine. * To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day. * To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG STP7 (mavoglurant)
  • DRUG Cocaine Hydrochloride

Study Locations (1)

Kansas

  • Altasciences Clinical Kansas — Overland Park

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2024-04-15
Est. Completion 2024-10-07
Phase Phase 1

Sponsor

Stalicla

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06273540

The ClinicalTrials.gov registry entry for NCT06273540 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stalicla, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cocaine Use Disorder appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06273540 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06273540 about?

NCT06273540 is a clinical study titled "Phase1, STP7 Cocaine Drug-Drug Interaction Study". This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age. The pri...

What is the current status of trial NCT06273540?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-04-15. Estimated completion is 2024-10-07.

What conditions does trial NCT06273540 study?

This clinical trial studies the following conditions: Cocaine Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06273540?

The interventions under investigation include: Placebo (DRUG), STP7 (mavoglurant) (DRUG), Cocaine Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06273540?

This trial is sponsored by Stalicla, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06273540 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial