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Clinical Rescue Protocol - 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000206
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : November 6, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of California, Los Angeles

Study Description
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Brief Summary:
The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Rescue Protocol
Study Start Date : April 1991
Actual Primary Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Retention
  2. Opiate use
  3. Opiate craving
  4. Adverse events

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to 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 ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Contacts and Locations
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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): NCT00000206


Locations
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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
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Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00000206    
Other Study ID Numbers: NIDA-06082-2
R18DA006082 ( U.S. NIH Grant/Contract )
R18-06082-2
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: November 6, 2016
Last Verified: November 2016
Keywords provided by University of California, Los Angeles:
Opioid
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists