Chantix for Treating Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
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

December 3, 2007
October 14, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00567008 on ClinicalTrials.gov Archive Site
Not Provided
Evidence of decreases in cocaine craving, demonstrated by scores on self-report measures of cocaine craving. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567008
806565, P60DA005186, NIDA P60DA0005186
Yes
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