Status:
WITHDRAWN
Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement
Lead Sponsor:
Jennifer Plebani
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Cocaine use, abuse and dependence is a public health problem that is directly responsible for hundreds of billions of dollars in health care expenditures per year. Relapse rates to cocaine use are hig...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females, 18 to 60 years old.
- Recreational users of cocaine reporting at least six instances of cocaine use in the past 12 months and at least one use in the past 30 days.
- 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 nicotine dependence, as determined by the Structured Clinical Interview for the DSM (SCID).
- Current severe psychiatric symptoms (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring anti-depressant therapy) as diagnosed using the SCID, the Hamilton Anxiety Rating Scale (Ham A), and Hamilton Ration Scale for Depression (HAM-D).
- Individuals scoring \> 10 on the Hamilton Rating Scale for Depression (HAM-D).
- Use of any investigational medication within the past 30 days.
- Concomitant treatment with psychotropic medications.
- Concomitant use of any one of the following drugs or classes of drugs:
- Reserpine
- Verapamil
- theophylline,
- trimethoprim,
- cimetidine,
- haloperidol,
- benzodiazepines, or
- antiepileptic drugs (AEDs).
- Patients with a known hypersensitivity to varenicline.
- Patients with severe concurrent illnesses such as bronchospastic disease, hyperthyroidism, diabetes mellitus.
- 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 method (diaphragm or condom) with spermicide
- Intrauterine progesterone contraceptive system
- Levonorgesterel implant
- Medroxyprogesterone acetate contraceptive injection, or
- Oral contraceptives.
- Patients with impaired renal function, as indicated by corrected creatinine clearance below 60 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
- An unacceptable liver panel (liver function tests; LFTs) that may be indicative of hepatic dysfunction.
- Clinical laboratory tests (e.g., CBC, blood chemistries, urinalysis) outside normal limits.
- History of significant heart disease or dysfunction (e.g., an arrhythmia which required medication, Wolff Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
- Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia, left-axis deviation, non-specific ST or T-wave changes.
- History of chest pain associated with cocaine use that prompted a visit to a physician.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01143857
Start Date
June 1 2010
End Date
August 1 2013
Last Update
October 16 2013
Active Locations (1)
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1
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104