Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBP-8000 100mg/Placebo | Experimental | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
|
| Placebo/RBP-8000 100mg | Experimental | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 |
|
| RBP-8000 200mg/Placebo | Experimental | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
|
| Placebo/RBP-8000 200mg | Experimental | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBP-8000 100 mg | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of Cocaine, (-)Ecgonine methyl ester and RBP-8000 | 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 | 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 | 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 | 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 | 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion | |
| Distribution half-life (t1/2α) of Cocaine | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral effects - as Measured by the Participant Using the Brief Substance Craving Scale | Post dosing 30 min,1,0, 2.0, 3.0, 4.0, 7.0, 8.0, 12.0,24.0 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bradley D Vince, DO | Vince and Associates Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6. |
|
| Cocaine | Drug | 50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6. |
|
|
| RBP-8000 200 mg | Drug | 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 |
|
|
| 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 | 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 | 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705990 | RBP-8000 |
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided