Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2007-12-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Varenicline (Chantix)
varenicline
1.0 mg BID for 8 weeks
2
Placebo
placebo
placebo BID for 8 weeks
Interventions
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varenicline
1.0 mg BID for 8 weeks
placebo
placebo BID for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Jennifer Plebani
Jennifer Plebani, PhD
Principal Investigators
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Jennifer G Plebani, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NIDA P60DA0005186
Identifier Type: -
Identifier Source: secondary_id
806565
Identifier Type: -
Identifier Source: org_study_id