Official Title: “A Double-Blind, Placebo Controlled Trial of Propranolol and Amantadine for the Treatment of Cocaine Dependent Subjects With Severe Cocaine Withdrawal Symptoms”

This study evaluates the efficacy of propranolol and amantadine in patients with severe cocaine withdrawal and cocaine craving.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2002

Intervention(s) in this Clinical Trial

• Drug: Propranolol
• Drug: Amantadine

Inclusion Criteria:

• Male and females, 18 to 60 years old.
• Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
• Initial CSSA score of 22 or greater. This score would place patients at risk of early treatment attrition and inability to attain abstinence based on previous cocaine pharmacotherapy trials conducted at this center.
• Continued use of cocaine during a two week evaluation phase prior to medication treatment as demonstrated by at least 2 new uses of cocaine documented by quantitative urine toxicology screen obtained every M, W, F according to new use rules (Preston et al., 1997).
• 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, marijuana, or nicotine dependence, as determined by the SCID.
• Concomitant treatment with psychotropic medications.
• 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 which has prompted a visit to a physician.
• Current use of reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines, or anticonvulsants.
• Patients with bronchospastic disease, hyperthyroidism, diabetes mellitus.
• Known hypersensitivity to propranolol or amantadine.
• Patients with known AIDS or other serious illnesses which 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.
• 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Kyle M Kampman, MD Principal Investigator University of Pensylvania  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00128349

Study ID Number: 33600

ClinicalTrials.gov Identifier: NCT00128349

Health Authority: United States: Food and Drug Administration