Chantix for Treating Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567008
• Other study ID #: 806565
• Secondary ID: P60DA005186NIDA
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2007
• Last updated: October 14, 2013
• Start date: December 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• varenicline
1.0 mg BID for 8 weeks
• placebo
placebo BID for 8 weeks

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.	Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.	8 weeks	No