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Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000299
First Posted: September 21, 1999
Last Update Posted: January 29, 2016
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles
  Purpose
The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.

Condition Intervention Phase
Opioid-Related Disorders Drug: Buprenorphine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rapid Opiate Detoxification & Naltrexone Induction Using Bup.

Resource links provided by NLM:


Further study details as provided by Walter Ling, University of California, Los Angeles:

Primary Outcome Measures:
  • Opiate craving [ Time Frame: 10 test days ]
    opiate craving is measured on each test day.

  • Opiate withdrawal symptoms [ Time Frame: 10 test days ]
    opiate withdrawal symptoms are documented for each test day


Enrollment: 12
Study Start Date: October 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: buprenorphine
depot buprenorphine
Drug: Buprenorphine
Experimental: buprenorphine and ultra-low dose naloxone
depot buprenorphine and naloxone
Drug: Buprenorphine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Males/Females, 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. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

  Contacts and Locations
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): NCT00000299


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.
  More Information

Responsible Party: Walter Ling, PI, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00000299     History of Changes
Other Study ID Numbers: NIDA-09260-2
P50DA009260 ( U.S. NIH Grant/Contract )
P50-09260-2
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: January 29, 2016
Last Verified: January 2016

Keywords provided by Walter Ling, University of California, Los Angeles:
Opioid-Related Disorders

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists