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Chantix for Treating Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00567008
First received: December 3, 2007
Last updated: October 14, 2013
Last verified: October 2013
Results First Received: July 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: varenicline
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-seven treatment-seeking participants from the greater metropolitan Philadelphia area were randomized to participate in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Varenicline 2mg/Day Varenicline (Chantix)
Placebo Placebo

Participant Flow:   Overall Study
    Varenicline 2mg/Day   Placebo
STARTED   18   19 
COMPLETED   17   18 
NOT COMPLETED   1   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varenicline Varenicline (Chantix)
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Varenicline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   37 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   18   19   37 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   5   5   10 
Male   13   14   27 
Region of Enrollment 
[Units: Participants]
     
United States   18   19   37 


  Outcome Measures

1.  Primary:   Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was a small preliminary trial, and thus was underpowered for anything less than large effects.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Plebani
Organization: UPenn
phone: 2152223200 ext 152
e-mail: jplebani@mail.med.upenn.edu



Responsible Party: Jennifer Plebani, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00567008     History of Changes
Other Study ID Numbers: 806565
P60DA005186 ( US NIH Grant/Contract Award Number )
NIDA P60DA0005186
Study First Received: December 3, 2007
Results First Received: July 17, 2013
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration