Cocaine-Related DisordersPhase 1NCT00087750
Interaction Between Cocaine and Quetiapine - 1
A Phase 1 study testing Quetiapine 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 the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels. 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?
- Quetiapine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to not given
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Includes but is not limited to: non-treatment seeking individuals. Must meet DSM-IV criteria for cocaine abuse or dependence. Must be able to verbalize understanding of consent and provide written informed consent and verbalize willingness to complete study procedures. Site will provide further details.
Who cannot join
- Please contact site for further information
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Interaction Between IV Cocaine and Quetiapine
The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels.
Read the detailed description
A placebo-controlled, double-blind, inpatient assessment of interaction between intravenous cocaine and quetiapine (seroquel) in cocaine-experienced subjects. To assess the safety of IV cocaine in subjects taking quetiapine at 3 dosage levels.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Quetiapine
- 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.
QuetiapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
pharmacokinetic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startOct 2003
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
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Domenic Ciraulo, M.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087750
- Sponsor's protocol ID
- NIDA-MDS-0001-1
- Status last verified
- Mar 2005
- First submitted
- 13 Jul 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
- Interaction Between IV Cocaine and Quetiapine
- ClinicalTrials.gov ID
- NCT00087750
- Acronym / sponsor ID
- NIDA-MDS-0001-1
- Conditions
- Cocaine-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Oct 2003
- First posted
- 16 Jul 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 the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels.
Detailed description
A placebo-controlled, double-blind, inpatient assessment of interaction between intravenous cocaine and quetiapine (seroquel) in cocaine-experienced subjects. To assess the safety of IV cocaine in subjects taking quetiapine at 3 dosage levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Includes but is not limited to: non-treatment seeking individuals. Must meet DSM-IV criteria for cocaine abuse or dependence. Must be able to verbalize understanding of consent and provide written informed consent and verbalize willingness to complete study procedures. Site will provide further details.
Key exclusion criteria (1 listed)
- Please contact site for further 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 |
|---|---|---|
| Quetiapine | Drug | – |
Primary outcome
Adverse events
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.
Domenic Ciraulo, M.D. principal investigator
Boston University
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 Quetiapine 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 1 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?
Adverse events. The study lists 2 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 11 Jan 2017.