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Glutamate Receptor Modulator

STP7 (mavoglurant) modified release film-coated tablet for Cocaine Use Disorder

Phase 1
Recruiting
Led By Debra Kelsh, MD
Research Sponsored by Stalicla SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females between 18 and 59 years of age, inclusive
Female participants must meet contraceptive criteria if of childbearing potential or be surgically sterile or in a menopausal state if not of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at day -2 at the time points (relative to the first infusion of the day): -30, - 15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 115, 125, 130, 135, 140, 145, 150, 165, 180, 210, 240, 270, 300, 330 and 360 minutes
Awards & highlights

Study Summary

This trial aims to study the effects of a drug called STP7 (mavoglurant) compared to a placebo on how people respond to intravenous cocaine. The study will involve non-t

Who is the study for?
This trial is for males and females aged 18-59 with a history of cocaine use who are not seeking treatment for their cocaine use disorder. Participants must have used cocaine at least six times in the past year, once in the last three months, and be willing to follow study procedures. They should have a BMI between 17.0 to 36.0 kg/m2 and weigh at least 50 kg.Check my eligibility
What is being tested?
The study tests if STP7 (mavoglurant) affects the body's response to intravenous cocaine by monitoring adverse events, heart rate, blood pressure, ECG readings including QT interval, as well as changes in how participants feel after taking cocaine.See study design
What are the potential side effects?
Potential side effects include reactions related to cardiovascular responses such as changes in heart rate or blood pressure from either mavoglurant or cocaine. Other side effects may arise from drug interactions affecting how one feels physically or mentally.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 59 years old.
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I am either using birth control, am surgically sterile, or am not able to have children due to menopause.
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I am a man who will use two forms of birth control and won't donate sperm.
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My BMI is between 17.0 and 36.0, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at day -2 at the time points (relative to the first infusion of the day): -30, - 15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 115, 125, 130, 135, 140, 145, 150, 165, 180, 210, 240, 270, 300, 330 and 360 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at day -2 at the time points (relative to the first infusion of the day): -30, - 15, 5, 10, 15, 20, 25, 30, 45, 55, 65, 70, 75, 80, 85, 90, 105, 115, 125, 130, 135, 140, 145, 150, 165, 180, 210, 240, 270, 300, 330 and 360 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion .
Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion.
Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.
+7 more
Secondary outcome measures
Craving evaluation of the STP7 on the subjective effects of cocaine.
Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7.
Pharmacokinetics: Clearance from plasma after oral administration of cocaine.
+30 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: STP7 (mavoglurant) modified release film-coated tabletExperimental Treatment1 Intervention
Participants will take STP7 (mavoglurant) twice a day (BID) from Days 3 to 9 according to the following dosing schedule: Day 3: 50 mg BID; Day 4: 100 mg BID; Days 5-9: 200 mg BID, Day 10: 200 mg only the morning dose. Morning STP7 (mavoglurant) doses must be taken within 30 minutes of beginning a meal.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take matched placebo on a dosing schedule identical to that of STP7 (mavoglurant) and morning doses must be taken within 30 minutes of beginning a meal.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stalicla SALead Sponsor
4 Previous Clinical Trials
1,748 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,619 Total Patients Enrolled
Debra Kelsh, MDPrincipal InvestigatorAltasciences Clinical Kansas, Inc.
13 Previous Clinical Trials
556 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being recruited for this clinical investigation?

"Indeed, the data on clinicaltrials.gov reveals that this investigation is actively seeking participants. The trial was initially disclosed on April 15th, 2024, with the most recent update occurring on April 17th, 2024. There are openings for 20 individuals at a single designated site."

Answered by AI

Are patients currently able to enroll in this ongoing clinical trial?

"Affirmative. Records on clinicaltrials.gov highlight the ongoing search for candidates to partake in this clinical investigation. Initially shared on April 15, 2024, and most recently revised on April 17, 2024, the study aims to enroll about twenty individuals from a single location."

Answered by AI

Does this medical investigation include individuals older than 45 years of age?

"Candidates aged 18 years or older but below 59 are eligible for recruitment into this study."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The main focus of this research is to observe ECG alterations (RR) post-STP7 therapy accompanied by cocaine infusion. This will be meticulously monitored at specified intervals on day 1, day 2, and up to day 10 following the initial dose administration. Secondary assessments include Pharmacokinetics: total area under the concentration-time curve from dosing initiation until infinity after benzoylecgonine intake; termed as Area under the concentration-time curve from time zero till infinity following benzoylecgonine ingestion., Pharmacokinetics: plasma clearance subsequent to oral cocaine consumption identified as Clearance from plasma post-oral administration (CL/F"

Answered by AI

Which individuals are eligible to take part in this clinical trial?

"Candidates must be experienced users not actively seeking treatment for cocaine addiction; both males and females within the specified age bracket are"

Answered by AI

Has the STP7 drug, also known as mavoglurant, been granted approval by the FDA in its modified release film-coated tablet form?

"The safety evaluation conducted by our team at Power for STP7 (mavoglurant) modified release film-coated tablet scored a 1 on the scale due to it being classified as a Phase 1 trial, indicating restricted data availability concerning its safety and effectiveness."

Answered by AI

Who else is applying?

What site did they apply to?
Altasciences Clinical Kansas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase1, STP7 Cocaine Drug-Drug Interaction Study
2024. "Phase1, STP7 Cocaine Drug-Drug Interaction Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06273540.
All > Kansas City
~13 spots leftby Sep 2024
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