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

Primary Purpose

Cocaine-Related Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Amantadine

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Amantadine, Cocaine, Pharmacotherapy, Outpatient

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Friends Research Institute

Outcomes

Primary Outcome Measures

Retention

Cocaine use

Cocaine craving

Psychosocial progress

Secondary Outcome Measures

Full Information

NCT ID

NCT00000301

First Posted

September 20, 1999

Last Updated

July 7, 2016

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00000301

Brief Title

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

Official Title

Rapid Evaluation of Cocaine Pharmacotherapies (Amantadine)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

March 1996 (undefined)

Primary Completion Date

June 1998 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary

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."

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine-Related Disorders

Keywords

Amantadine, Cocaine, Pharmacotherapy, Outpatient

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

Double

Allocation

Randomized

Enrollment

0 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amantadine

Primary Outcome Measure Information:

Title

Retention

Title

Cocaine use

Title

Cocaine craving

Title

Psychosocial progress

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter Ling, M.D.

Organizational Affiliation

Friends Research Institute, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friends Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12062456

Citation

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. doi: 10.1016/s0376-8716(01)00205-8.

Results Reference

background

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

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