Clinical Trials Logo
  1. Home
  2. Cocaine-Related Disorders
  3. NCT00158132

Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2

Cocaine-Related Disorders Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00158132
Study type Interventional
Source National Institute on Drug Abuse (NIDA)
Contact
Status Completed
Phase Phase 2
Start date September 1999
Completion date February 2006
View Details
See also
  Status Clinical Trial Phase
Completed NCT01526538 - Improving Learning-based Treatment of Cocaine Dependence With Medication Phase 2
Completed NCT00877435 - Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial N/A
Completed NCT00430690 - Acoustic Startle Reduction In Cocaine Dependence
Completed NCT00217997 - Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals N/A
Active, not recruiting NCT00094315 - Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1 Phase 1
Terminated NCT00142883 - The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3 N/A
Completed NCT00218348 - Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo Phase 2
Completed NCT00142844 - Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1 Phase 2
Completed NCT00015054 - Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3 Phase 2
Completed NCT00000294 - Effects of Carvedilol on Cocaine Use in Humans - 11 Phase 2
Completed NCT00000308 - Dextroamphetamine-Cocaine Behavioral Intervention - 5 Phase 2
Completed NCT00000277 - Mazindol for Cocaine Abuse - 2 Phase 2
Completed NCT00000280 - Glutaminergic Agents for Cocaine Abuse - 5 Phase 1
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000188 - Selegiline in Treatment of Cocaine Dependence - 2 Phase 2
Completed NCT00000278 - Disulfiram for Cocaine-Alcohol Abuse - 3 Phase 2
Completed NCT00000314 - M-CPP and Fenfluramine in Cocaine Addicts - 3 Phase 2
Completed NCT00000281 - Pharmacotherapy for Schizophrenic Drug Users - 6 Phase 2
Completed NCT00000282 - Pemoline for Cocaine Abuse - 7 Phase 2
Terminated NCT00000276 - Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Phase 1