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Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00134914
First received: August 23, 2005
Last updated: July 11, 2008
Last verified: July 2008
  Purpose

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.


Condition Intervention
Opioid-Related Disorders
Drug: Buprenorphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Opioid agonist rating [ Time Frame: up to one day ] [ Designated as safety issue: Yes ]
  • opiate withdrawal [ Time Frame: up to one day ] [ Designated as safety issue: Yes ]
  • physiologic measures [ Time Frame: up to one day ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 1996
Study Completion Date: May 1998
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Buprenorphine
    single doses given by sublingual and parenteral routes
Detailed Description:

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.

This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently opioid dependent
  • In good health, as determined by a pre-participation medical examination
  • Seeking and eligible for methadone maintenance or detoxification treatment

Exclusion Criteria:

  • Significant medical or psychiatric illness, other than drug dependence
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134914

Locations
United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823
Sponsors and Collaborators
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00134914     History of Changes
Other Study ID Numbers: NIDA-08045-4, R01-08045-4, DPMC
Study First Received: August 23, 2005
Last Updated: July 11, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014