Cocaine-Related DisordersPhase 1NCT00033098
Cocaine-Metyrapone Interaction Study - 1
A Phase 1 study testing Metyrapone in people with Cocaine-Related Disorders and Infusions, Intravenous, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine-Related Disorders, Infusions, Intravenous
- What is being tested?
- Metyrapone
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to May 2002
- 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
- Male or Females between 18 and 45 yrs of age; cocaine dependence according to DSM-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments.
Who cannot join
- Additional criteria available during screening at the site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
About this study
Official title: Cocaine-Metyrapone Interaction Study
The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.
Read the detailed description
To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week. Secondary study goals are to evaluate the possible efficacy of MRP as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. This study will utilize a Double Blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.
- Conditions
- Cocaine-Related Disorders, Infusions, Intravenous
- Being tested
- Metyrapone
- 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.
MetyraponeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine craving
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2002 (estimated)
- Study startNov 2001
- Study completionMay 2002
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
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cincinnati VA Medical Center
- Investigators
- Theresa Winhusen, Ph.D., Principal investigator, Cincinnati VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033098
- Sponsor's protocol ID
- NIDA-CTO-0006-1
- Status last verified
- Aug 2003
- First submitted
- 5 Apr 2002
- 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
- Cocaine-Metyrapone Interaction Study
- ClinicalTrials.gov ID
- NCT00033098
- Acronym / sponsor ID
- NIDA-CTO-0006-1
- Conditions
- Cocaine-Related Disorders, Infusions, Intravenous
- 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
- Collaborators
- Cincinnati VA Medical Center
- Study start
- Nov 2001
- Study completion
- May 2002
- First posted
- 8 Apr 2002 (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 examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.
Detailed description
To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week. Secondary study goals are to evaluate the possible efficacy of MRP as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. This study will utilize a Double Blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- 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)
- Male or Females between 18 and 45 yrs of age; cocaine dependence according to DSM-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments.
Key exclusion criteria (1 listed)
- Additional criteria available during screening at the site.
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 |
|---|---|---|
| Metyrapone | Drug | – |
Primary outcome
Cocaine craving
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.
Theresa Winhusen, Ph.D. principal investigator
Cincinnati VA Medical Center
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 Metyrapone in people with Cocaine-Related Disorders and Infusions, Intravenous, 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?
Cocaine craving. 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.