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Chantix for Treating Cocaine Dependence

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), May 2008

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00567008
  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 II

ChemIDplus related topics:   Varenicline    Acetylcholine    Acetylcholine chloride    8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))-    Cocaine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Evidence of abstinence from cocaine as indicated by qualitative urinalysis for benzoylecgonine. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of decreases in cocaine craving, demonstrated by scores on self-report measures of cocaine craving. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Varenicline (Chantix)
Drug: varenicline
1.0 mg BID for 8 weeks
2: Placebo Comparator
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 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Males and females, 18 to 70 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.
  • 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.
  • Patients mandated to treatment based upon a legal decision or as a condition of employment.
  • 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 reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines, or anticonvulsants.
  • Patients with bronchospastic disease, hyperthyroidism, diabetes mellitus.
  • 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.
  • 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     Recruiting
      Philadelphia, Pennsylvania, United States, 19104 6178
      Contact: Donna Simpson     215-243-9959     simpson_d@mail.trc.upenn.edu    
      Principal Investigator: Jennifer G Plebani, PhD            
      Principal Investigator: Kyle M Kampman, MD            
      Sub-Investigator: Helen M Pettianti, PhD            
      Sub-Investigator: Charles P O'Brien, MD/PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Jennifer G Plebani, PhD     University of Pennsylvania    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   University of Pennsylvania ( Jennifer G. Plebani, PhD )
Study ID Numbers:   806565, NIDA P60DA0005186
First Received:   December 3, 2007
Last Updated:   May 6, 2008
ClinicalTrials.gov Identifier:   NCT00567008
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine  
crack cocaine  
cocaine-related disorders  
substance-related disorders  
alpha4beta2 nicotinic acetylcholine receptor  

Study placed in the following topic categories:
Cocaine-Related Disorders
Dopamine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Acetylcholine
Cocaine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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