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Baclofen for the Treatment of Cocaine Dependence - 1

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baclofen
Placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine Dependence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must have DSM-IV diagnosis of cocaine dependence. Subject must be seeking treatment for cocaine dependence. Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures. Exclusion Criteria: Please contact site for more information.

Sites / Locations

  • San Francisco General Hosptial
  • Torrance Site
  • Denver VA Medical Center
  • VA Maryland Healthcare System
  • U of Penn School of Medicine
  • South TX VA Health Care System
  • Salt Lake City VA Medical Center
  • Institute of Resch & Educ Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Effects of medication on cocaine craving

Secondary Outcome Measures

Full Information

First Posted
May 11, 2004
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00082485
Brief Title
Baclofen for the Treatment of Cocaine Dependence - 1
Official Title
Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.
Detailed Description
Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Effects of medication on cocaine craving

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have DSM-IV diagnosis of cocaine dependence. Subject must be seeking treatment for cocaine dependence. Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures. Exclusion Criteria: Please contact site for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liza Gorgon, M.A.
Organizational Affiliation
VA Maryland Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hosptial
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Torrance Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
VA Maryland Healthcare System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
U of Penn School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104 6178
Country
United States
Facility Name
South TX VA Health Care System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284 4404
Country
United States
Facility Name
Salt Lake City VA Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Institute of Resch & Educ Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042 3300
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19414226
Citation
Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 Jul 1;103(1-2):59-64. doi: 10.1016/j.drugalcdep.2009.03.011. Epub 2009 May 2.
Results Reference
result

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Baclofen for the Treatment of Cocaine Dependence - 1

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