|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00567008 |
Purpose
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.
| Condition | Intervention | Phase |
|
Cocaine Dependence |
Drug: varenicline Drug: placebo |
Phase II |
| ChemIDplus related topics: | Varenicline Acetylcholine Acetylcholine chloride 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence |
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Varenicline (Chantix)
|
Drug: varenicline
1.0 mg BID for 8 weeks
|
|
2: Placebo Comparator
Placebo
|
Drug: placebo
placebo BID for 8 weeks
|
The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Acceptable methods of birth control include:
Contacts and Locations| United States, Pennsylvania | |||||
| University of Pennsylvania | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104 6178 | |||||
| Contact: Donna Simpson 215-243-9959 simpson_d@mail.trc.upenn.edu | |||||
| Principal Investigator: Jennifer G Plebani, PhD | |||||
| Principal Investigator: Kyle M Kampman, MD | |||||
| Sub-Investigator: Helen M Pettianti, PhD | |||||
| Sub-Investigator: Charles P O'Brien, MD/PhD | |||||
| Principal Investigator: | Jennifer G Plebani, PhD | University of Pennsylvania |
More Information
Related Info 
  |
| Responsible Party: | University of Pennsylvania ( Jennifer G. Plebani, PhD ) |
| Study ID Numbers: | 806565, NIDA P60DA0005186 |
| First Received: | December 3, 2007 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00567008 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|