Chantix for Treating Cocaine Dependence
This study has been completed.
Information provided by:
National Institute on Drug Abuse (NIDA)
First received: December 3, 2007
Last updated: July 29, 2010
Last verified: June 2010
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence
Primary Outcome Measures:
- Evidence of abstinence from cocaine as indicated by qualitative urinalysis for benzoylecgonine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evidence of more cocaine non-use days during the medication treatment and decreases in cocaine craving, demonstrated by scores on self-report measures of cocaine craving. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
1.0 mg BID for 8 weeks
Other Name: Chantix
Placebo Comparator: 2
placebo BID for 8 weeks
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567008
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104 6178 |
||Jennifer G Plebani, PhD
||University of Pennsylvania
No publications provided
||Jennifer G. Plebani, PhD, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
||806565, NIDA P60DA0005186
|Study First Received:
||December 3, 2007
||July 29, 2010
||United States: Food and Drug Administration
Keywords provided by National Institute on Drug Abuse (NIDA):
alpha4beta2 nicotinic acetylcholine receptor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents