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

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ClinicalTrials.gov Identifier: NCT00134875
Recruitment Status : Terminated
First Posted : August 25, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Study Start Date : December 2000
Primary Completion Date : December 2002
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Opioid agonist effects [ Time Frame: 3.5 hours ]
  2. Physiologic measures [ Time Frame: 3.5 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00134875

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)
Principal Investigator: Eric C. Strain, M.D. Johns Hopkins University

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
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence

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