Alcohol-Related DisordersPhase 1NCT00094289
Interactions Between Cocaine and Ethanol and Disulfiram - 1
A Phase 1 study testing Disulfiram in people with Alcohol-Related Disorders and Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alcohol-Related Disorders, Cocaine-Related Disorders
- What is being tested?
- Disulfiram
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment.
- Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements.
Who cannot join
- Please contact site for more information.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Integrated Substance Abuse Program
Los Angeles, California, 90024
University of Texas Hlth Sci Ctr San Ant
San Antonio, Texas, 78284 7828
About this study
Official title: Interactions Between IV Cocaine and Ethanol and Oral Disulfiram
The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.
Read the detailed description
This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.
- Being tested
- Disulfiram
- Medical subject headings
- Alcohol-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DisulfiramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
Psychological effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startAug 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-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
- 16 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- John Roache, Ph.D., Principal investigator, University of Texas Health Sci Cntr, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094289
- Sponsor's protocol ID
- NIDA-MDS-0003-1
- Status last verified
- Jul 2005
- First submitted
- 15 Oct 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
- Interactions Between IV Cocaine and Ethanol and Oral Disulfiram
- ClinicalTrials.gov ID
- NCT00094289
- Acronym / sponsor ID
- NIDA-MDS-0003-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 2004
- Study completion
- Jul 2005
- First posted
- 15 Oct 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 potential interactions between intravenous cocaine and ethanol and oral disulfiram.
Detailed description
This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment.
- Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements.
Key exclusion criteria (1 listed)
- Please contact 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 |
|---|---|---|
| Disulfiram | Drug | – |
Primary outcome
Safety assessments
Psychological effects
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.
John Roache, Ph.D. principal investigator
University of Texas Health Sci Cntr, San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Disulfiram in people with Alcohol-Related Disorders and Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 2 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 2 sites 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?
Safety assessments. 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.