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CompletedNCT00082485Updated Jan 12, 2017

Baclofen for the Treatment of Cocaine Dependence - 1

A Phase 2 interventional study of Baclofen and Placebo in Cocaine-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 8 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-01-12.

Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Cocaine-Related Disorders

Keywords

  • Cocaine Dependence
03

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 160 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Please contact site for more information.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Active comparator
    1

    Drug: Baclofen

  • Placebo comparator
    2

    Other: Placebo

Interventions

  • DrugBaclofen

    Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8)

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Effects of medication on cocaine craving

07

Study locations

8 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 19414226 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00082485
Lead sponsor
National Institute on Drug Abuse (NIDA)
First posted
May 12, 2004
Start date
Jun 2004
Primary completion
Jul 2006
Last update
Jan 12, 2017

Study contacts

Liza Gorgon, M.A.
principal investigator · VA Maryland Health Care System
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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