Cocaine-Related DisordersPhase 2NCT00000286
Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3
A Phase 2 study testing Nefazodone 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 determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Nefazodone
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1996to Dec 2001
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence
Who cannot join
- Unstable medical illness, dx of MR, OBS, bipolar
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Effects of Nefazodone on Treatment of Female Cocaine Abusers
The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.
Read the detailed description
This study evaluated the effect of nefazodone on reducing cocaine use and craving in both depressed and nondepressed women and if there was a greater effect in depressed women.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Nefazodone
- Keywords
- cocaine dependence
- 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.
NefazodoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
Drug use
Depression
Life functioning
HIV risk behaviors
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 startDec 1996
- Study completionDec 2001
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
- Masking
- Double blind
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Minnesota
- Investigators
- Dorothy Hatsukami, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000286
- Sponsor's protocol ID
- NIDA-09259-3
- Other IDs
- P50-09259-3
- Status last verified
- Oct 2016
- First submitted
- 20 Sep 1999
- Last updated
- 12 Jan 2017
- Results posted
- No
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
- Effects of Nefazodone on Treatment of Female Cocaine Abusers
- ClinicalTrials.gov ID
- NCT00000286
- Acronym / sponsor ID
- NIDA-09259-3
- Conditions
- Cocaine-Related Disorders
- Keywords
- cocaine dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Minnesota
- Study start
- Dec 1996
- Study completion
- Dec 2001
- 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 determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.
Detailed description
This study evaluated the effect of nefazodone on reducing cocaine use and craving in both depressed and nondepressed women and if there was a greater effect in depressed women.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence
Key exclusion criteria (1 listed)
- Unstable medical illness, dx of MR, OBS, bipolar
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 |
|---|---|---|
| Nefazodone | Drug | – |
Primary outcome
Craving
Drug use
Depression
Life functioning
HIV risk behaviors
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 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.
Dorothy Hatsukami, Ph.D. principal investigator
University of Minnesota
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 Nefazodone 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: finished, 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 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?
Craving. 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 12 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.