Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

NCT00032929 — Phase 3, Completed, 269 participants, National Institute on Drug Abuse (NIDA)
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence

RegistryNCT00032929
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, crossover, masking: quadruple, treatment
Enrollment269 (Actual)
SponsorNational Institute on Drug Abuse (NIDA) (Nih); collaborators: Somerset Pharmaceuticals
ConditionsCocaine-Related Disorders
InterventionsSelegiline (Drug)
Datesstart 2001-03-01, primary completion 2002-12-01, first posted 2002-04-08, last updated 2017-01-12
Locations16 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cocaine-Related Disorders All trials of Selegiline

-Summary

The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.

Expand all sections  ·  Collapse all

+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).

+Arms and interventions

  • Selegiline (Drug)

+Outcome measures

Primary outcomes

  • Weekly mean proportion of cocaine non-use days
  • Measured reductions in cocaine and other drug use

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

\- Additional Criteria available during the screening process at the site.

+Locations (16)

FacilityCityCountryStatus
Tucson VA Medical CenterTucson, ArizonaUnited States
Haight-Ashbury Free ClinicBerkeley, CaliforniaUnited States
Friends Research Institute-2Los Angeles, CaliforniaUnited States
Friends Research InstituteLos Angeles, CaliforniaUnited States
San Francisco General HosptialSan Francisco, CaliforniaUnited States
San Francisco VA Medical CenterSan Francisco, CaliforniaUnited States
Denver VA Medical CenterDenver, ColoradoUnited States
New Orleans VA Medical CenterNew Orleans, LouisianaUnited States
VA Maryland Healthcare SystemBaltimore, MarylandUnited States
Wayne State UniversityDetroit, MichiganUnited States
Cincinnati VA Medical CenterCincinnati, OhioUnited States
Medical University of South CarolinaCharleston, South CarolinaUnited States
VA North Texas Health Care SystemDallas, TexasUnited States
University of Texas Hlth Sci Ctr HoustonHouston, TexasUnited States
Salt Lake City VA Medical CenterSalt Lake City, UtahUnited States
VA Puget Sound Health Care SystemSeattle, WashingtonUnited States

+Publications

  • Results publication: 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. PMID 16730924

+Investigators