Chantix for Treating Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: varenicline; placebo
Intervention description: 1.0 mg BID for 8 weeks; placebo BID for 8 weeks
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cocaine; crack cocaine; cocaine-related disorders; substance-related disorders; alpha4beta2 nicotinic acetylcholine receptor

Summary:

      The purpose of this study is to determine whether varenicline (Chantix), is effective for the
      treatment of cocaine dependence.
    

Eligibility criteria:

        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).