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A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT01680887
Recruitment Status : Recruiting
First Posted : September 7, 2012
Last Update Posted : September 8, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a double-blind placebo-controlled clinical trial (n = 200) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Varenicline Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind Trial of Varenicline for the Treatment of Cocaine Dependence
Study Start Date : August 2012
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Varenicline
Oral 1.0 mg BID.
Drug: Varenicline
Other Name: Chantix
Placebo Comparator: Placebo
Oral 1.0 mg BID.
Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Number of participants who report cocaine use and have positive urine drug screens in the Chantix group versus the placebo group comparator [ Time Frame: Three times per week in weeks 2 through 13 ]
    Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield daily use/no-use indicators for each study day of treatment.

Secondary Outcome Measures :
  1. Number of participants who are compliant with taking medications in the Chantix group versus the placebo group comparator [ Time Frame: Three times per week during weeks 2 through 13 ]
    Measured through observed dosing at three-times-weekly clinic visits and weekly pill counts on the basis of self-reports and examination of blister packs.

  2. Number of participants who report cocaine craving in the Chantix group versus the placebo group comparator [ Time Frame: Once per week in weeks 2 through 13 ]
    As measured by weekly scores on the Cocaine Craving Questionnaire (CCQ) and the Minnesota Cocaine Craving Scale (MCC) during the medication treatment phase.

  3. Number of participants who have smoked cigarettes, both in isolation and in relation to cocaine use in the Chantix group versus the placebo group comparator. [ Time Frame: Once per week in weeks 2 through 13 ]
    Measured by carbon monoxide (CO) by CO monitor and cotinine levels using urinary cotinine dipstick testing at each clinic visit.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680887

Contact: Kathleen Feeney 215-222-3200 ext 143 kfeen@mail.med.upenn.edu

United States, Pennsylvania
University of Pennsylvania Treatment Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Jennifer G Plebani, PhD         
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Jennifer G Plebani, PhD University of Pennsylvania
More Information

Additional Information:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01680887     History of Changes
Other Study ID Numbers: 814643
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by University of Pennsylvania:
Cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents