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).
Age range
18 Years – 59 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of Treatment-Emergent Adverse Events.
Timeframe: On day -2, day -1, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day10, day 11, day 12 and the follow-up (window from day 19 to day 26).
Heart Rate response following the STP7 treatment with the cocaine infusion.
Timeframe: 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
Heart Rate response following the STP7 treatment with the cocaine infusion.
Timeframe: Collected at day 1, day 2, day 9 and day 10 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, 120, 150, 180, 210, 240, 270 and 300 minutes
Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion .
Timeframe: 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
Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion.
Timeframe: Collected at day 1, day 2, day 9 and day 10 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, 120, 150, 180, 210, 240, 270 and 300 minutes
Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.
Timeframe: 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
Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion.
Timeframe: Collected at day 1, day 2, day 9 and day 10 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, 120, 150, 180, 210, 240, 270 and 300 minutes
ECG changes (HR) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.
ECG changes (RR) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.
ECG changes (PR) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.
ECG changes (QRS) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.
ECG changes (QT) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day -2 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 105, 125, 130, 135, 150, 165, 180 and 360 minutes after the first infusion.
ECG changes (HR) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.
ECG changes (RR) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.
ECG changes (PR) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.
ECG changes (QRS) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.
ECG changes (QT) following the STP7 treatment with the cocaine infusion.
Timeframe: As collected at day 1, day 2, day 9 and day 10 at -10 minutes and at 5, 10, 15, 30, 45, 65, 70, 75, 90, 120, 150, 180 and 300 minutes after the first infusion.