Baclofen for the Treatment of Cocaine Dependence - 1
Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
1 other identifier
interventional
160
1 country
8
Brief Summary
The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2004
CompletedFirst Posted
Study publicly available on registry
May 12, 2004
CompletedStudy Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedJanuary 12, 2017
August 1, 2016
2.1 years
May 11, 2004
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of medication on cocaine craving
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Please contact site for more information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
San Francisco General Hosptial
San Francisco, California, 94110, United States
Torrance Site
Torrance, California, 90502, United States
Denver VA Medical Center
Denver, Colorado, 80220, United States
VA Maryland Healthcare System
Baltimore, Maryland, 21201, United States
U of Penn School of Medicine
Philadelphia, Pennsylvania, 19104 6178, United States
South TX VA Health Care System
San Antonio, Texas, 78284 4404, United States
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148, United States
Institute of Resch & Educ Inova Fairfax Hospital
Falls Church, Virginia, 22042 3300, United States
Related 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 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.
PMID: 19414226RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liza Gorgon, M.A.
VA Maryland Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 11, 2004
First Posted
May 12, 2004
Study Start
June 1, 2004
Primary Completion
July 1, 2006
Last Updated
January 12, 2017
Record last verified: 2016-08