Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4

This study has been completed.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000301

Purpose

The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, amantadine is tested."

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Amantadine	Phase II

Drug Information available for: Amantadine Amantadine hydrochloride Amantadine sulfate 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Rapid Evaluation of Cocaine Pharmacotherapies (Amantadine)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Retention
Cocaine use
Cocaine craving
Psychosocial progress

Estimated Enrollment:	0
Study Start Date:	March 1996

Detailed Description:

16-week participation plus a 2 weekk lead-in period. Participants are assigned randomly to placebo or amantadine. Participants attend group meeting 3 times/week

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

M/F, ages 18-65. cocaine dependence according to DMS-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000301

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

Publications:

Shoptaw S, Kintaudi PC, Charuvastra C, Ling W. A screening trial of amantadine as a medication for cocaine dependence. Drug Alcohol Depend. 2002 May 1;66(3):217-24.

Study ID Numbers:	NIDA-09260-4, P50-09260-4
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000301
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Cocaine
Amantadine

Additional relevant MeSH terms:

Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Antiviral Agents
Pharmacologic Actions

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009