Cocaine AbusePhase 1NCT00218049
Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals
A Phase 1 study testing GBR 12909 in people with Cocaine Abuse and Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Abuse, Cocaine-Related Disorders
- What is being tested?
- GBR 12909
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 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
- Meets DSM-IV criteria for current cocaine dependence
- Not currently seeking treatment for cocaine dependence
- Currently uses cocaine, as determined by a self-report and a positive urine test for cocaine, within 30 days prior to study entry
- Within 20 % of ideal body weight, and weighs at least 100 lbs
- Good general health
- Normal electrocardiogram
- Willing to use acceptable methods of contraception for the duration of the study
Who cannot join
- Current or history of a major psychiatric illness, other than drug dependence or disorders secondary to drug abuse
- Meets DSM-IV criteria for dependence on any drugs other than cocaine, marijuana, nicotine, or alcohol
- Physiologically dependent on alcohol and requires medical detoxification
- Use of prescription drugs within 14 days prior to study entry
- Use of non-prescription drugs within 7 days prior to study entry
- If female, used an oral contraceptive, Depo-Provera, Norplant, or intrauterine progesterone contraceptive system, within 30 days prior to study entry
Show all 20Show fewer
- Pregnant or breastfeeding
- History of liver disease
- Current elevated aspartate aminotransferase or alanine aminotransferase levels
- Donated a unit of blood within 4 weeks prior to study entry
- Participated in any other clinical investigation within 4 weeks prior to study entry
- History of any illness or behavior that, in the opinion of the investigator, might interfere with the study
- Family history of early significant cardiovascular disease
- Exhibits Hepatitis B surface antigen or Hepatitis C antibody
- HIV infected
- Syphilis
- Active tuberculosis
- Adult asthma
- Chronic obstructive pulmonary disease
- Unable to distinguish between 20 mg and 40 mg of intravenous cocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Phase 1, Double-blind, Placebo-controlled Assessment of Interactions Between 2 Doses of Cocaine and Three Doses of Escalating Vanoxerine (GBR 12909) in Cocaine Using Volunteers
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.
Read the detailed description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Dopamine transporters (DAT) play an important role in the addictive nature of cocaine; the use of compounds that target DAT may be effective in treating cocaine dependent individuals. Research shows that GBR 12909 has a strong affinity for DAT. The purpose of this study is to determine the safety and potential interaction of GBR 12909 and cocaine in cocaine dependent individuals.
- Conditions
- Cocaine Abuse, 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
50mg GBR 12909 over 12 days
GBR 12909Drug
GBR 12909 75 mg over 12 day period
GBR 12909Drug
GBR 12909 100 mg over 12 day period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 50 mg of GBR 12909 Receives: Drug: GBR 12909 |
| 2 | Experimental | 75 mg of GBR 12909 Receives: Drug: GBR 12909 |
| 3 | Experimental | 100 mg of GBR 12909 Receives: Drug: GBR 12909 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication effects, including frequency of adverse events
Measured: 12 days of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2005
- Study completionJul 2005
Why it stopped: Issue of priority of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AbuseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Texas
- Investigators
- John Grabowski, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218049
- Sponsor's protocol ID
- NIDA-09262-10
- Other IDs
- P50-09262-10, DPMC
- Status last verified
- Aug 2008
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double-blind, Placebo-controlled Assessment of Interactions Between 2 Doses of Cocaine and Three Doses of Escalating Vanoxerine (GBR 12909) in Cocaine Using Volunteers
- ClinicalTrials.gov ID
- NCT00218049
- Acronym / sponsor ID
- NIDA-09262-10
- Conditions
- Cocaine Abuse, Cocaine-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issue of priority of resources
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Texas
- Study start
- Dec 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 22 Sep 2005 (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.
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.
Detailed description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Dopamine transporters (DAT) play an important role in the addictive nature of cocaine; the use of compounds that target DAT may be effective in treating cocaine dependent individuals. Research shows that GBR 12909 has a strong affinity for DAT. The purpose of this study is to determine the safety and potential interaction of GBR 12909 and cocaine in cocaine dependent individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GBR 1290950 mg of GBR 12909 |
| 2 | Experimental | Drug: GBR 1290975 mg of GBR 12909 |
| 3 | Experimental | Drug: GBR 12909100 mg of GBR 12909 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meets DSM-IV criteria for current cocaine dependence
- Not currently seeking treatment for cocaine dependence
- Currently uses cocaine, as determined by a self-report and a positive urine test for cocaine, within 30 days prior to study entry
- Within 20 % of ideal body weight, and weighs at least 100 lbs
- Good general health
Key exclusion criteria (20 listed)
- Current or history of a major psychiatric illness, other than drug dependence or disorders secondary to drug abuse
- Meets DSM-IV criteria for dependence on any drugs other than cocaine, marijuana, nicotine, or alcohol
- Physiologically dependent on alcohol and requires medical detoxification
- Use of prescription drugs within 14 days prior to study entry
- Use of non-prescription drugs within 7 days prior to study entry
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 1290950mg GBR 12909 over 12 days | Drug | 1 |
| GBR 12909GBR 12909 75 mg over 12 day period | Drug | 2 |
| GBR 12909GBR 12909 100 mg over 12 day period | Drug | 3 |
Primary outcome
Medication effects, including frequency of adverse events
Time frame: 12 days of trial
Results and safety
The study was stopped early (reason given: Issue of priority of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
John Grabowski, PhD principal investigator
University of Texas
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 Abuse and 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 7 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 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?
The study was stopped early (reason given: Issue of priority of resources). 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?
Medication effects, including frequency of adverse events (time frame: 12 days of trial). 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 12 Jan 2017.