Cocaine-Related DisordersPhase 1NCT00089687
GBR 12909 Study in Cocaine Experienced African American Volunteers - 1
A Phase 1 study testing GBR 12909 in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- GBR 12909
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to May 2005
- Phase
- Phase 1
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be within 20% of ideal body weight and must weigh at least 45 kg.
- Must understand the study procedures and provide written informed consent.
- Must meet DSM-4 criteria for abuse or dependence on cocaine.
- Must be non-treatment seeking at the time of the study.
Who cannot join
- Please contact the study site for more information.
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of Health Science
Bethesda, Maryland, 20814 4799
About this study
Official title: GBR 12909 Study in Cocaine Experienced African American Volunteers
The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.
Read the detailed description
Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.
- Conditions
- Cocaine-Related Disorders
- Being tested
- GBR 12909
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR 12909Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2004 (estimated)
- Study startApr 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Louis Cantilena, M.D., Principal investigator, Uniformed Services University of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089687
- Sponsor's protocol ID
- NIDA-CPU-0005-1
- Status last verified
- Jan 2005
- First submitted
- 10 Aug 2004
- Last updated
- 11 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GBR 12909 Study in Cocaine Experienced African American Volunteers
- ClinicalTrials.gov ID
- NCT00089687
- Acronym / sponsor ID
- NIDA-CPU-0005-1
- Conditions
- Cocaine-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2004
- Study completion
- May 2005
- First posted
- 11 Aug 2004 (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.
The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.
Detailed description
Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be within 20% of ideal body weight and must weigh at least 45 kg.
- Must understand the study procedures and provide written informed consent.
- Must meet DSM-4 criteria for abuse or dependence on cocaine.
- Must be non-treatment seeking at the time of the study.
Key exclusion criteria (1 listed)
- Please contact the study site for more information.
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 |
|---|---|---|
| GBR 12909 | Drug | – |
Primary outcome
pharmacokinetic assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
Louis Cantilena, M.D. principal investigator
Uniformed Services University of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GBR 12909 in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
pharmacokinetic assessment. 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 11 Jan 2017.