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NCT06273540 · ClinicalTrials.gov registry record · Phase 1
Phase1, STP7 Cocaine Drug-Drug Interaction Study
A Phase 1 study of Cocaine Use Disorder, sponsored by Stalicla.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06273540: Completed Phase 1 study of Cocaine Use Disorder, sponsored by Stalicla.
NCT06273540 is a Phase 1 study of Cocaine Use Disorder that has completed, run by Stalicla. The registered enrollment target is 21 participants, below the 103-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06273540, a Phase 1 study of Cocaine Use Disorder, has completed, sponsored by Stalicla.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Any events spontaneously reported by the participant or observed by the investigative staff will also be recorded.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG STP7 (mavoglurant)
- DRUG Cocaine Hydrochloride
Study Locations (1)
Kansas
- Altasciences Clinical Kansas - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-04-15 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 1 |
What the finished NCT06273540 record still lists
NCT06273540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 103-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (80% lower).
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.
NCT06273540 reports a single indexed study location in Kansas.
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.
What interventions are being tested in trial NCT06273540?
The interventions under investigation include: Placebo (DRUG), STP7 (mavoglurant) (DRUG), Cocaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06273540?
This trial is sponsored by Stalicla, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cocaine Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06273540's enrollment target sits among peer trials
21 24th of 26 higher than 3 of 26 other Cocaine Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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