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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 7, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE April 1991
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
  • Retention
  • Opiate use
  • Opiate craving
  • Adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Opiate craving
  • Adverse events
  • Retention
  • Opiate use
Change History Complete list of historical versions of study NCT00000206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Rescue Protocol - 2
Official Title  ICMJE Clinical Rescue Protocol
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Opioid-Related Disorders
Intervention  ICMJE Drug: Buprenorphine
Study Arms  ICMJE Not Provided
Publications * Ling W, Shoptaw S, Wesson D, Rawson RA, Compton M, Klett CJ. Treatment effectiveness score as an outcome measure in clinical trials. NIDA Res Monogr. 1997;175:208-20. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
0
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000206
Other Study ID Numbers  ICMJE NIDA-06082-2
R18DA006082 ( U.S. NIH Grant/Contract )
R18-06082-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
PRS Account University of California, Los Angeles
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP