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

December 3, 2007
December 4, 2007
July 17, 2013
November 7, 2013
November 7, 2013
December 2007
September 2009   (Final data collection date for primary outcome measure)
Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine. [ Time Frame: 8 weeks ]
Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.
Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine. [ Time Frame: 9 weeks ]
Complete list of historical versions of study NCT00567008 on Archive Site
Not Provided
Evidence of decreases in cocaine craving, demonstrated by scores on self-report measures of cocaine craving. [ Time Frame: 9 weeks ]
Not Provided
Not Provided
Chantix for Treating Cocaine Dependence
A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: varenicline
    1.0 mg BID for 8 weeks
    Other Name: Chantix
  • Drug: placebo
    placebo BID for 8 weeks
  • Experimental: 1
    Varenicline (Chantix)
    Intervention: Drug: varenicline
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, 18 to 65 years old.
  • Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
  • Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
  • Understands and signs the informed consent.

Exclusion Criteria:

  • Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine or nicotine dependence, as determined by the SCID.
  • Concomitant treatment with psychotropic medications.
  • Current or prior gambling problems. This will be assessed by the patient's self-report.
  • Patients mandated to treatment based upon a legal decision or as a condition of employment. This will be assessed by the patient's self-report.
  • Current severe psychiatric symptoms, e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant therapy in the opinion of the Principal Investigator (PI)
  • Use of any investigational medication within the past 30 days.
  • History of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
  • History of chest pain associated with cocaine use that has prompted a visit to a physician.
  • Current use of naltrexone, disulfiram, modafinil, stimulants, reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines or anticonvulsants.
  • Known hypersensitivity to varenicline.
  • Patients with known AIDS or other serious illnesses that may require hospitalization during the study.
  • Female subjects who are pregnant or lactating, or female subjects of child-bearing potential who are not using acceptable methods of birth control.

Acceptable methods of birth control include:

  • barrier (diaphragm or condom) with spermicide
  • intrauterine progesterone contraceptive system
  • levonorgestrel implant
  • medroxyprogesterone acetate contraceptive injection
  • oral contraceptives.
  • tubal ligation.
  • Patients with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
  • Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <5 x ULN are acceptable).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P60DA005186 ( U.S. NIH Grant/Contract )
NIDA P60DA0005186
Not Provided
Not Provided
Jennifer Plebani, University of Pennsylvania
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jennifer G Plebani, PhD University of Pennsylvania
University of Pennsylvania
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP