Chantix for Treating Cocaine Dependence

NCT00567008 | Completed Phase 2 Results DMC

• 3 other identifiers: 806565P60DA005186NIDA P60DA0005186
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Dependence

Keywords

cocaine; crack cocaine; cocaine-related disorders; substance-related disorders; alpha4beta2 nicotinic acetylcholine receptor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Varenicline (Chantix)

Drug: varenicline

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

varenicline DRUG

1.0 mg BID for 8 weeks

Also known as: Chantix

1

placebo DRUG

placebo BID for 8 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

This study was a small preliminary trial, and thus was underpowered for anything less than large effects.

Results Point of Contact

• Title: Jennifer Plebani
• Organization: UPenn

jplebani@mail.med.upenn.edu

2152223200

Study Officials

• Jennifer G Plebani, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jennifer Plebani, PhD

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 4, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 7, 2013
• Results First Posted: November 7, 2013

Record last verified: 2013-10

Locations

US (1)