CompletedNCT01846481RBP-8000Updated Sep 23, 2016

A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse

A Phase 2 interventional study of RBP-8000 100 mg and Placebo in Opioid Dependence, Opioid Related Disorders and Cocaine Dependence, sponsored by Indivior Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Indivior Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 21 Years to 50 Years
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Opioid Dependence
Opioid Related Disorders
Cocaine Dependence

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Keywords

Cocaine

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

Indivior Inc. is the lead sponsor of 51 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

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
Drug: RBP-8000 100 mg · Drug: Placebo · Drug: Cocaine
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
Drug: RBP-8000 100 mg · Drug: Placebo · Drug: Cocaine
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
Drug: Placebo · Drug: Cocaine · Drug: RBP-8000 200 mg
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
Drug: Placebo · Drug: Cocaine · Drug: RBP-8000 200 mg

Interventions

DrugRBP-8000 100 mg
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
Also known as: T172R/G173G cocaine esterase
DrugPlacebo
IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6.
DrugCocaine
50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6.
Also known as: Benzoylmethylecgonine
DrugRBP-8000 200 mg
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
Also known as: T172R/G173G cocaine esterase

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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

Study locations

1 site

Vince and Associates Clinical Research
Overland Park,, Kansas 66212, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01846481
Lead sponsor: Indivior Inc.
Responsible party: Sponsor
First posted: May 3, 2013
Start date: Apr 2013
Primary completion: Jun 2013
Completion: Jun 2013
Last update: Sep 23, 2016

Study contacts

Bradley D Vince, DO

principal investigator · Vince and Associates Clinical Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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