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Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

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ClinicalTrials.gov Identifier: NCT00000299
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 29, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rapid Opiate Detoxification & Naltrexone Induction Using Bup.
Study Start Date : October 2008
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: buprenorphine
depot buprenorphine
Drug: Buprenorphine
Experimental: buprenorphine and ultra-low dose naloxone
depot buprenorphine and naloxone
Drug: Buprenorphine

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

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

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

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.

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

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

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 )
First Posted: September 21, 1999    Key Record Dates
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
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists