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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01680887
First received: August 28, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Cocaine Dependence
Drug: Varenicline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind Trial of Varenicline for the Treatment of Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    As measured by weekly scores on the Cocaine Craving Questionnaire (CCQ) and the Minnesota Cocaine Craving Scale (MCC) during the medication treatment phase.

  • 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 ] [ Designated as safety issue: No ]
    Measured by carbon monoxide (CO) by CO monitor and cotinine levels using urinary cotinine dipstick testing at each clinic visit.


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline
Oral 1.0 mg BID.
Drug: Varenicline
Other Name: Chantix
Placebo Comparator: Placebo
0 mg daily for 12 weeks.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680887

Contacts
Contact: Donna Simpson 215-243-9959 addicted@med.upenn.edu

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

Additional Information:
No publications provided

Responsible Party: Jennifer Plebani, Sponsor-Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01680887     History of Changes
Other Study ID Numbers: 814643
Study First Received: August 28, 2012
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Cocaine dependence

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

ClinicalTrials.gov processed this record on August 28, 2014