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NCT00082485 Clinical Trial

Baclofen for the Treatment of Cocaine Dependence - 1

Cocaine-Related Disorders Clinical Trial

Official title:
Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00082485
Other study ID # NIDA-CSP-1021-1
Secondary ID
Status Completed
Phase Phase 2
First received May 11, 2004
Last updated January 11, 2017
Start date June 2004

Study information
Verified date August 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.

Description:

Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

Other known NCT identifiers
  • NCT00431938

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Baclofen
Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)
Other:
• Placebo
Placebo

Locations
Country Name City State
United States VA Maryland Healthcare System Baltimore Maryland
United States Denver VA Medical Center Denver Colorado
United States Institute of Resch & Educ Inova Fairfax Hospital Falls Church Virginia
United States U of Penn School of Medicine Philadelphia Pennsylvania
United States Salt Lake City VA Medical Center Salt Lake City Utah
United States South TX VA Health Care System San Antonio Texas
United States San Francisco General Hosptial San Francisco California
United States Torrance Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 initia — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Effects of medication on cocaine craving
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