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

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Amantadine, a medication that improves muscle control, and propranolol, a medication that lowers blood pressure, may be useful in treating cocaine addiction in individuals with severe cocaine withdrawal symptoms. This study will evaluate the effectiveness of amantadine and propranolol in preventing drug relapse among cocaine addicts.

Study Type: Interventional

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

Study Primary Completion Date: March 2005

Cocaine withdrawal symptoms are a major contributing factor for why outpatient cocaine dependence treatment programs often fail. Individuals with severe cocaine withdrawal symptoms often experience anxiety, shaking, and muscle pain. Amantadine is a medication currently used to improve muscle control, reduce shaking, and lessen stiffness. Therefore, it may help reduce the muscle pain that some cocaine addicts experience. By enhancing activity of the brain chemical dopamine, amantadine may also reduce other symptoms associated with cocaine withdrawal. Propranolol is a medication currently used to treat high blood pressure and irregular heart rhythms. It may reduce anxiety and lessen cocaine cravings in individuals addicted to cocaine. The purpose of this study is to evaluate the effectiveness of amantadine and propranolol, alone and in combination, for treating cocaine addicts with severe cocaine withdrawal symptoms.

A 2-week baseline evaluation period will be followed by an 8-week treatment phase. During the baseline evaluation, cocaine use will be measured with urine tests, three times each week.

Only participants who are experiencing severe withdrawal symptoms and who use cocaine at least twice during the first 2 weeks will continue in the study. Eligible individuals will then be randomly assigned to receive amantadine alone, propranolol alone, a combination of amantadine and propranolol, or placebo. Treatments will begin at Week 3 and study visits will occur three times each week. Cocaine levels will be monitored throughout the study with urine tests.

Intervention(s) in this Clinical Trial

• Drug: Propranolol

Primary Measures

• Cocaine abstinence; measured throughout the study

Inclusion Criteria:

• Meets DSM-IV diagnosis criteria for cocaine dependence as determined by the Structured
• Clinical Interview for DSM-IV (SCID)
• Score of at least 22 on the Initial Cocaine Selective Severity Assessment (CSSA)
• Lives within commuting distance of the Treatment Research Center (TRC) and the Penn/VA
• Center for Studies of Addiction, University of Pennsylvania
• If female, willing to use contraception throughout the study
• Continued use of cocaine during the 2-week baseline evaluation period will be a requirement for continuation in the study

Exclusion Criteria:

• Meets DSM-IV/SCID diagnosis criteria for dependence on any drugs other than cocaine, marijuana, or nicotine
• Currently taking psychotropic medications
• Current severe psychiatric symptoms (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant medication)
• Sensitivity to propranolol or amantadine
• Use of any other research study medication within 30 days prior to study entry
• History of significant heart disease, 1st degree heart block, sinus tachycardia, left axis deviation, or nonspecific ST or T wave changes
• History of chest pain associated with cocaine use that has required medical attention
• Current use of reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines, or anticonvulsants
• Bronchospastic disease
• Hyperthyroidism
• Diabetes mellitus
• Infected with AIDS or other serious illness that may require hospitalization during the study
• Impaired kidney function
• Abnormal laboratory test results
• Liver function tests (LFTs) five times greater than normal
• Pregnant or breastfeeding
• Required to obtain treatment based upon a legal decision or as a condition of employment

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

Helen M. Pettinati, Ph.D. Principal Investigator University of Pennsylvania  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00158132

Study ID Number: NIDA-12756-2

ClinicalTrials.gov Identifier: NCT00158132

Health Authority: United States: Food and Drug Administration