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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00158132 |
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.
Condition | Intervention | Phase |
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Cocaine-Related Disorders |
Drug: Propranolol Drug: Amantadine Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo Controlled Trial of Propranolol and Amantadine for the Treatment of Cocaine Dependent Subjects With Severe Cocaine Withdrawal Symptoms |
Enrollment: | 199 |
Study Start Date: | September 1999 |
Study Completion Date: | February 2006 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Propranolol: Experimental
Propranolol 100mg/day in 3 divided doses
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Drug: Propranolol
Propranolol 100mg/day in 3 divided doses
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Amantadine: Experimental
Amantadine 100mg three times daily
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Drug: Amantadine
Amantadine 100mg three times daily
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Propranolol and Amantadine: Experimental
Propranolol 100mg/day in 3 divided doses and Amantadine 100mg 3X's daily
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Drug: Propranolol
Propranolol 100mg/day in 3 divided doses
Drug: Amantadine
Amantadine 100mg three times daily
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Placebo: Placebo Comparator
Identical Placebo pills
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Drug: Placebo
Placebo pills
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 6178 |
Principal Investigator: | Helen M. Pettinati, Ph.D. | University of Pennsylvania |
Responsible Party: | Treatment Research Center, University of Pennsylvania ( Dr. Kyle Kampman ) |
Study ID Numbers: | NIDA-12756-2, P50-12756-2, DPMC |
Study First Received: | September 8, 2005 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00158132 |
Health Authority: | United States: Food and Drug Administration |
Cocaine-Related Disorders Dopamine Propranolol Mental Disorders |
Substance-Related Disorders Disorders of Environmental Origin Cocaine Amantadine |
Anti-Infective Agents Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Cardiovascular Agents Antihypertensive Agents Antiviral Agents |
Pharmacologic Actions Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Dopamine Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents |