Cocaine-Related DisordersPhase 2NCT00000213
IV Cocaine Abuse: A Laboratory Model - 2
A Phase 2 study testing Fluoxetine in people with Cocaine-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Fluoxetine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1990to Apr 1991
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Please contact site for information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IV Cocaine Abuse: A Laboratory Model
The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Fluoxetine
- Keywords
- intravenous abuse
- 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.
FluoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct cocaine effects
Interaction of cocaine/fluox. on cardio measures
Interaction of cocaine/fluox. on coc's subjective
Effects of fluoxetine on cocaine craving
Drug use during outpatient fluoxetine maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startApr 1990
- Primary completionApr 1991
- Study completionApr 1991
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 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Responsible party
- Sponsor
- Investigators
- Richard Foltin, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000213
- Sponsor's protocol ID
- NIDA-06234-2
- Other IDs
- R01DA006234, R01-06234-2
- Status last verified
- Dec 2012
- First submitted
- 20 Sep 1999
- Last updated
- 28 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Cocaine Abuse: A Laboratory Model
- ClinicalTrials.gov ID
- NCT00000213
- Acronym / sponsor ID
- NIDA-06234-2
- Conditions
- Cocaine-Related Disorders
- Keywords
- intravenous abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Columbia University
- Study start
- Apr 1990
- Primary completion
- Apr 1991 (actual)
- Study completion
- Apr 1991 (actual)
- First posted
- 21 Sep 1999 (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 evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Fluoxetine | Drug | – |
Primary outcome
Direct cocaine effects
Interaction of cocaine/fluox. on cardio measures
Interaction of cocaine/fluox. on coc's subjective
Effects of fluoxetine on cocaine craving
Drug use during outpatient fluoxetine maintenance
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 28 Aug 2015.
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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.
Richard Foltin, Ph.D. principal investigator
Columbia University
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 Fluoxetine in people with Cocaine-Related Disorders, run by New York State Psychiatric Institute 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?
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 28 Aug 2015. 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?
Direct cocaine effects. The study lists 5 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 28 Aug 2015.