Clinical trial NCT00567008: Chantix for Treating Cocaine Dependence
Official title: A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: cocaine
crack cocaine
cocaine-related disorders
substance-related disorders
alpha4beta2 nicotinic acetylcholine receptor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-12-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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).

Primary outcomes:
measure: Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jennifer G Plebani, PhD
role: PRINCIPAL_INVESTIGATOR
References: