Chantix for Treating Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Plebani, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00567008
First received: December 3, 2007
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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


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 Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.


Enrollment: 37
Study Start Date: December 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Varenicline (Chantix)
Drug: varenicline
1.0 mg BID for 8 weeks
Other Name: Chantix
Placebo Comparator: 2
Placebo
Drug: placebo
placebo BID for 8 weeks

Detailed Description:

The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567008

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jennifer G Plebani, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jennifer Plebani, Jennifer Plebani, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00567008     History of Changes
Other Study ID Numbers: 806565, P60DA005186, NIDA P60DA0005186
Study First Received: December 3, 2007
Results First Received: July 17, 2013
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
cocaine
crack cocaine
cocaine-related disorders
substance-related disorders
alpha4beta2 nicotinic acetylcholine receptor

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

ClinicalTrials.gov processed this record on April 14, 2014