A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Varenicline; Placebo
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: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cocaine dependence

Summary:

      This is a double-blind placebo-controlled clinical trial (n = 156) of varenicline for the
      treatment of cocaine dependence that utilizes contingency management to promote treatment
      attendance.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, 18 to 65 years old.

          2. Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical
             Interview for DSM-IV (SCID).

          3. 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.

          4. Understands and signs the informed consent.

        Exclusion Criteria:

          1. Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
             alcohol, or nicotine dependence, as determined by the SCID.

          2. Subject is, in the investigator's opinion, at risk of requiring medical detoxification
             for alcohol dependence during the study.

          3. Concomitant treatment with psychotropic medications.

          4. Current gambling problems. This will be assessed by the patient's self-report.

          5. Patients mandated to treatment based upon a legal decision or as a condition of
             employment who will use participation in this study to fulfill to their court mandated
             treatment requirement.This will be assessed by the patient's self-report.

          6. 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).

          7. Use of any investigational medication within the past 30 days.

          8. Subject has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis,
             regional enteritis, or gastrointestinal bleeding) disease.

          9. Current use of naltrexone, disulfiram, modafinil, stimulants, haloperidol,
             benzodiazepines or anticonvulsants.

         10. Known hypersensitivity to varenicline.

         11. Patients with known AIDS or other serious illnesses that may require hospitalization
             during the study.

         12. 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:

               1. barrier (diaphragm or condom) with spermicide

               2. intrauterine progesterone contraceptive system

               3. levonorgestrel implant

               4. medroxyprogesterone acetate contraceptive injection

               5. oral contraceptives

               6. tubal ligation.

         13. Patients with impaired renal function as indicated by corrected creatinine clearance
             below 60 ml/min as determined by the modified Cockcroft equation (CDC, 1986).

         14. Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits
             that are clinically unacceptable to the Medical Director. 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).