This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.
There will be a 28-day screening period with eligible subjects remaining resident in the clinic from the evening before Day -1 up and until the morning of Day 9. On the morning of Day 1, a 50 mg intravenous (IV) infusion of cocaine will be administered over 10 minutes to all subjects. If none of the stopping criteria were met and no intervening safety concerns, subjects will be randomized to one of the treatment sequences on Day 3. On dosing days, Day 3 and Day 6, subjects will have fasted at least 8 hours before dosing of cocaine and either RBP-8000 200 mg, RBP-8000 100 mg or matching placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6
IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6.
50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6.
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Maximum plasma concentration (Cmax) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Time to Maximum Plasma Concentration (Tmax) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Elimination half-life (t1/2) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Area under the plasma concentration-time curve from time 0 to theoretical infinity (AUC0-inf) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Distribution half-life (t1/2α) of Cocaine
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Clearance (CL) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Volume of distribution (Vd) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Elimination rate constant (λz) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
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RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Mean residence time (MRT) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Time frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Behavioral effects - as Measured by the Participant Using the Brief Substance Craving Scale
Time frame: Post dosing 30 min,1,0, 2.0, 3.0, 4.0, 7.0, 8.0, 12.0,24.0 hours