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Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

This study has been terminated.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00134875
First received: August 23, 2005
Last updated: October 27, 2008
Last verified: October 2008
History of Changes
  Purpose

Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals. However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in non-dependent opioid abusers.


Condition Intervention
Opioid-Related Disorders
 Drug: Buprenorphine/naloxone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Opioid agonist effects [ Time Frame: 3.5 hours ] [ Designated as safety issue: Yes ]
  • Physiologic measures [ Time Frame: 3.5 hours ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: December 2000
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Buprenorphine/naloxone
    Acute doses of buprenorphine/naloxone in each experimental test session. Doses delivered by either sublingual or parenteral routes, and are: 4/1, 8/2, 16/4 mg.
Detailed Description:

Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal. While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's agonist effects, especially if administered parenterally. The purpose of this study is to assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and buprenorphine/naloxone in non-dependent opioid abusers.

Participants will stay on a research ward and will undergo challenge sessions twice per week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological status will be recorded continuously and tasks assessing psychomotor, subjective, and objective status will be performed repeatedly.

  Eligibility

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

Inclusion Criteria:

  • Non-dependent opioid abuser
  • Actively abusing opioids by injection

Exclusion Criteria:

  • Opioid dependence
  • Signs or symptoms of opioid withdrawal, once admitted to residential unit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134875

Locations
United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Eric C. Strain, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00134875     History of Changes
Other Study ID Numbers: NIDA-08045-3, R01-08045-3, DPMC
Study First Received: August 23, 2005
Last Updated: October 27, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 13, 2013