Cocaine-Related DisordersPhase 3NCT00032929
Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1
A Phase 3 study testing Selegiline in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 16 sites in United States.
Trial summary
The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Selegiline
- How many people
- 269 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2001to Dec 2002
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female
- At least 18 years of age
- DSM-4 diagnosis of cocaine dependence
- Ability to understand and provide written consent
- Female subjects must use acceptable birth control
Who cannot join
- Additional Criteria available during the screening process at the site.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
VA Maryland Healthcare System
Baltimore, Maryland, 21201
Haight-Ashbury Free Clinic
Berkeley, California, 94704
Medical University of South Carolina
Charleston, South Carolina, 29425 742
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
VA North Texas Health Care System
Dallas, Texas, 75216
Denver VA Medical Center
Denver, Colorado, 80220
Wayne State University
Detroit, Michigan, 48207
University of Texas Hlth Sci Ctr Houston
Houston, Texas, 77030
Friends Research Institute-2
Los Angeles, California, 90025
Friends Research Institute
Los Angeles, California, 90025
New Orleans VA Medical Center
New Orleans, Louisiana, 70112
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148
San Francisco General Hosptial
San Francisco, California, 94110
San Francisco VA Medical Center
San Francisco, California, 94121
VA Puget Sound Health Care System
Seattle, Washington, 98108
Tucson VA Medical Center
Tucson, Arizona, 85723
About this study
Official title: Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence
The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.
Read the detailed description
The study objectives are to assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline treatment compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
- Conditions
- Cocaine-Related Disorders
- Being tested
- Selegiline
- 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.
SelegilineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean proportion of cocaine non-use days
Measured reductions in cocaine and other drug use
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 startMar 2001
- Primary completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Somerset Pharmaceuticals
- Investigators
- Ahmed Elkashef, MD, Study chair, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032929
- Sponsor's protocol ID
- NIDA-CSP-1019-1
- Status last verified
- May 2009
- First submitted
- 5 Apr 2002
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Elkashef A, Fudala PJ, Gorgon L, Li SH, Kahn R, Chiang N, Vocci F, Collins J, Jones K, Boardman K, Sather M. Double-blind, placebo-controlled trial of selegiline transdermal system (STS) for the treatment of cocaine dependence. Drug Alcohol Depend. 2006 Dec 1;85(3):191-7. doi: 10.1016/j.drugalcdep.2006.04.010. Epub 2006 May 30.
PubMed 16730924
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
- Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00032929
- Acronym / sponsor ID
- NIDA-CSP-1019-1
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Somerset Pharmaceuticals
- Study start
- Mar 2001
- Primary completion
- Dec 2002 (actual)
- 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 evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.
Detailed description
The study objectives are to assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline treatment compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male/Female
- At least 18 years of age
- DSM-4 diagnosis of cocaine dependence
- Ability to understand and provide written consent
- Female subjects must use acceptable birth control
Key exclusion criteria (1 listed)
- Additional Criteria available during the screening process 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 |
|---|---|---|
| Selegiline | Drug | – |
Primary outcome
Weekly mean proportion of cocaine non-use days
Measured reductions in cocaine and other drug use
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.
- Results publication: PubMed 16730924Elkashef A, Fudala PJ, Gorgon L, Li SH, Kahn R, Chiang N, Vocci F, Collins J, Jones K, Boardman K, Sather M. Double-blind, placebo-controlled trial of selegiline transdermal system (STS) for the treatment of cocaine dependence. Drug Alcohol Depend. 2006 Dec 1;85(3):191-7. doi: 10.1016/j.drugalcdep.2006.04.010. Epub 2006 May 30.
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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.
Ahmed Elkashef, MD study chair
National Institute on Drug Abuse (NIDA)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selegiline in people with Cocaine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 16 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 5 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 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Weekly mean proportion of cocaine non-use days. 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?
On the ClinicalTrials.gov record for NCT00032929, which also lists 1 linked publication.
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.