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Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

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ClinicalTrials.gov Identifier: NCT00000303
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, Los Angeles

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, baclofen is tested.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Baclofen Phase 2

Detailed Description:
16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 0 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)
Study Start Date : October 1997
Primary Completion Date : May 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Retention
  2. Cocaine use
  3. Cocaine craving
  4. Psychosocial progress


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000303


Locations
United States, California
Friends Research Institute
Los Angeles, California, United States, 90025
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.

Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00000303     History of Changes
Other Study ID Numbers: NIDA-09260-6
P50DA009260 ( U.S. NIH Grant/Contract )
P50-09260-6
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by University of California, Los Angeles:
Cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents