Opioid DependencePhase 2RBP-8000NCT01846481
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse
A Phase 2 study testing RBP-8000 100 mg, Cocaine and RBP-8000 200 mg in people with Opioid Dependence and Opioid Related Disorders, run by Indivior Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Opioid Related Disorders, Cocaine Dependence
- What is being tested?
- RBP-8000 100 mg, Cocaine and RBP-8000 200 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: 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
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.
- Being tested
- RBP-8000 100 mg, Placebo, Cocaine, RBP-8000 200 mg
- Keywords
- Cocaine
- Medical subject headings
- Opioid-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBP-8000 100 mgDrug
Also called T172R/G173G cocaine esterase
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
PlaceboDrug
IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6.
CocaineDrug
Also called Benzoylmethylecgonine
50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6.
RBP-8000 200 mgDrug
Also called T172R/G173G cocaine esterase
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: RBP-8000 100 mg; Drug: Placebo; Drug: Cocaine |
| 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 Receives: Drug: RBP-8000 100 mg; Drug: Placebo; Drug: Cocaine |
| 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 Receives: Drug: Placebo; Drug: Cocaine; Drug: RBP-8000 200 mg |
| 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 Receives: Drug: Placebo; Drug: Cocaine; Drug: RBP-8000 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of Cocaine, (-)Ecgonine methyl ester and RBP-8000
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Distribution half-life (t1/2α) of Cocaine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 21 samples from pre-dose of cocaine up to 731 minutes after start of cocaine infusion
Secondary outcomes (1)
Behavioral effects - as Measured by the Participant Using the Brief Substance Craving Scale
Measured: Post dosing 30 min,1,0, 2.0, 3.0, 4.0, 7.0, 8.0, 12.0,24.0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley D Vince, DO, Principal investigator, Vince and Associates Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846481
- Sponsor's protocol ID
- RB-US-13-0004
- Acronym
- RBP-8000
- Status last verified
- Sep 2016
- First submitted
- 1 May 2013
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01846481
- Acronym / sponsor ID
- RBP-8000 / RB-US-13-0004
- Keywords
- Cocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RBP-8000 100mg/Placebo | Experimental | Drug: RBP-8000 100 mg, Drug: Placebo, Drug: CocaineDay 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 | Drug: RBP-8000 100 mg, Drug: Placebo, Drug: CocaineDay 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 | Drug: Placebo, Drug: Cocaine, Drug: RBP-8000 200 mgDay 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 | Drug: Placebo, Drug: Cocaine, Drug: RBP-8000 200 mgDay 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 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBP-8000 100 mgAlso: T172R/G173G cocaine esteraseRBP-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 | Drug | Placebo/RBP-8000 100mg, RBP-8000 100mg/Placebo |
| PlaceboIV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6. | Drug | Placebo/RBP-8000 100mg, Placebo/RBP-8000 200mg, RBP-8000 100mg/Placebo, RBP-8000 200mg/Placebo |
| CocaineAlso: Benzoylmethylecgonine50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6. | Drug | Placebo/RBP-8000 100mg, Placebo/RBP-8000 200mg, RBP-8000 100mg/Placebo, RBP-8000 200mg/Placebo |
| RBP-8000 200 mgAlso: T172R/G173G cocaine esteraseRBP-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 | Drug | Placebo/RBP-8000 200mg, RBP-8000 200mg/Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley D Vince, DO principal investigator
Vince and Associates Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBP-8000 100 mg, Cocaine and RBP-8000 200 mg in people with Opioid Dependence and Opioid Related Disorders, run by Indivior Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.