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Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158132
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 12, 2017
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Propranolol Drug: Amantadine Drug: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled Trial of Propranolol and Amantadine for the Treatment of Cocaine Dependent Subjects With Severe Cocaine Withdrawal Symptoms
Study Start Date : September 1999
Actual Primary Completion Date : March 2005
Actual Study Completion Date : February 2006

Arm Intervention/treatment
Experimental: Propranolol
Propranolol 100mg/day in 3 divided doses
Drug: Propranolol
Propranolol 100mg/day in 3 divided doses

Experimental: Amantadine
Amantadine 100mg three times daily
Drug: Amantadine
Amantadine 100mg three times daily

Experimental: Propranolol and Amantadine
Propranolol 100mg/day in 3 divided doses and Amantadine 100mg 3X's daily
Drug: Propranolol
Propranolol 100mg/day in 3 divided doses

Drug: Amantadine
Amantadine 100mg three times daily

Placebo Comparator: Placebo
Identical Placebo pills
Drug: Placebo
Placebo pills

Primary Outcome Measures :
  1. Cocaine abstinence; measured by self-reported Time line follow-back and confirmed with cocaine urine tests. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and females, 18 to 60 years old.
  • Meets DSM-IV diagnosis criteria for cocaine dependence as determined by the Structured Clinical Interview for DSM-IV (SCID)
  • Score of at least (> or =) 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 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 three times weekly according to new use rules

Exclusion Criteria:

  • Meets DSM-IV/SCID diagnosis criteria for dependence on any drugs other than cocaine, marijuana, or nicotine. Cocaine dependent subjects who identify cocaine dependence as their primary addiction but who also meet criteria for alcohol dependence will be accepted as long as the alcohol dependence is not severe enough to require medications for alcohol detoxification.
  • 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 medication)
  • Sensitivity to propranolol or amantadine
  • 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
  • Bronchospastic disease
  • Hyperthyroidism
  • Diabetes mellitus
  • 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:

    1. barrier (diaphragm or condom) with spermicide
    2. intrauterine progesterone contraceptive system
    3. levonorgestrel implant
    4. medroxyprogesterone acetate contraceptive injection
    5. 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). A complete list of exclusionary lab results are included in the appendix 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158132

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104 6178
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Helen M. Pettinati, Ph.D. University of Pennsylvania

Additional Information:
Publications of Results:
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Responsible Party: Dr. Kyle Kampman, Treatment Research Center, University of Pennsylvania Identifier: NCT00158132     History of Changes
Obsolete Identifiers: NCT00128349
Other Study ID Numbers: NIDA-12756-2
P50DA012756-02 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents