Chantix for Treating Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567008
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : November 7, 2013
Last Update Posted : November 7, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: varenicline
Drug: placebo

  Participant Flow

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
Varenicline 2mg/Day Varenicline (Chantix)
Placebo Placebo

Participant Flow:   Overall Study
    Varenicline 2mg/Day   Placebo
STARTED   18   19 
COMPLETED   17   18 

  Baseline Characteristics

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
Varenicline Varenicline (Chantix)
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Varenicline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   37 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   18   19   37 
>=65 years   0   0   0 
[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

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

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

Responsible Party: Jennifer Plebani, University of Pennsylvania Identifier: NCT00567008     History of Changes
Other Study ID Numbers: 806565
P60DA005186 ( U.S. NIH Grant/Contract )
NIDA P60DA0005186
First Submitted: December 3, 2007
First Posted: December 4, 2007
Results First Submitted: July 17, 2013
Results First Posted: November 7, 2013
Last Update Posted: November 7, 2013