- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846481
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse (RBP-8000)
A Randomized, Double-blind, Placebo-controlled, Dose of RBP-8000 Following IV Cocaine to Evaluate the Pharmacokinetics Parameters of RBP-8000 and Cocaine and to Assess the Effects of Drug on Cocaine-induced Physiologic and Behavioral Effects in Cocaine Abusing Subjects
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kansas
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Overland Park,, Kansas, United States, 66212
- Vince and Associates Clinical Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female volunteers aged 21-50 years, inclusive
- Body mass index (BMI)18-32 kg/m^2 and weight of at least 50 kg
- Not currently seeking treatment for substance abuse or substance dependence
- Subject is healthy, in the opinion of the Principal Investigator other than cocaine abuse; as determined by the absence of clinically significant medical/psychiatric history or findings, particularly cardiovascular or central nervous system (CNS) disease, physical examination, normal renal function, ECG findings, vital signs, and laboratory results at screening
- Males agree to refrain from sperm donations for the entire duration of the study, and for at least 90 days after the last dose of study drug
- Has experience using cocaine by the smoked or IV route at least 6 times in past 12 months and a positive urine drug screen for cocaine prior to study intake (Day -2). Has experience using cocaine by the smoked or IV route in the past 3 months and a positive urine drug screen for cocaine during screening prior to study check-in at the clinic
- Be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, prior to the initiation of any protocol-specific procedures
- Meet DSM-IV-TR criteria for current cocaine abuse
- Be able to comply with protocol requirements, rules, and regulations of the study site, and be likely to complete all the study procedures in the opinion of the Principal Investigator
Exclusion Criteria:
- Current or past history of seizure disorder, including alcohol- and/or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder. Have any previous clinically significant reaction to cocaine, including loss of consciousness or seizure
- Current alcohol dependence or current drug dependence according to DSM-IV-TR criteria (excluding nicotine and caffeine)
- Clinically significant history of cardiac disease, including cardiovascular and conduction abnormalities or ECG evidence of cardiac abnormalities
- QTcF greater than or equal to 450 for male subjects and 470 for female subjects as measured through a 12-lead ECG
- History of liver disease or current elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 3x the upper limit of normal
- Be on probation or parole, and/or have current or pending legal charges with the potential for incarceration that could interfere with the study scheduling
- Women with a positive pregnancy test at screening; or women who are pregnant or lactating or who are seeking to become pregnant
- Women of childbearing potential (who are sexually active with a male) who fail to use medically acceptable contraception methods (e.g., an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, a double barrier method, or barrier plus spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilization, e.g., bilateral tubal ligation, bilateral ovariectomy (oophorectomy). Females that are post-menopausal will be confirmed as such by the follicle stimulating hormone (FSH) test at initial screening
- Males who do not agree to use barrier contraception and spermicide when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication
- History of clinically significant severe allergic or anaphylactic reactions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RBP-8000 100mg/Placebo
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 |
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
Other Names:
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.
Other Names:
|
Experimental: Placebo/RBP-8000 100mg
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 100 mg administered in the vein on either study day 3 or 6.
There is a 72-hour washout between Days 3 and 6
Other Names:
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.
Other Names:
|
Experimental: RBP-8000 200mg/Placebo
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 |
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.
Other Names:
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
Other Names:
|
Experimental: Placebo/RBP-8000 200mg
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 |
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.
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
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21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
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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
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21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
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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
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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
Time Frame: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
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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
|
21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Post dosing 30 min,1,0, 2.0, 3.0, 4.0, 7.0, 8.0, 12.0,24.0 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Anesthetics, Local
- Dopamine Uptake Inhibitors
- Vasoconstrictor Agents
- Cocaine
Other Study ID Numbers
- RB-US-13-0004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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