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Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00032929
Enrollment
269
Registered
2002-04-08
Start date
2001-03-31
Completion date
Unknown
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders

Keywords

Cocaine Dependence

Brief summary

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).

Interventions

Sponsors

Somerset Pharmaceuticals
CollaboratorINDUSTRY
National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026