Clinical Rescue Protocol - 2

• ClinicalTrials.gov Identifier: NCT00000206
• Recruitment Status: Completed
• First Posted: September 21, 1999
• Last Update Posted: November 6, 2016
• Sponsor: University of California, Los Angeles
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by: University of California, Los Angeles

Tracking Information

• First Submitted Date: September 20, 1999
• First Posted Date: September 21, 1999
• Last Update Posted Date: November 6, 2016
• Study Start Date: April 1991
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 16, 2005)

• Retention
• Opiate use
• Opiate craving
• Adverse events

Original Primary Outcome Measures (submitted: June 23, 2005)

• Opiate craving
• Adverse events
• Retention
• Opiate use

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Rescue Protocol - 2
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Masking: Double; Primary Purpose: Treatment
• Condition: Opioid-Related Disorders
• Intervention: Drug: Buprenorphine
• Study Arms: 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. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 0
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00000206
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Walter Ling, M.D.; Friends Research Institute, Inc.

• PRS Account: University of California, Los Angeles
• Verification Date: November 2016