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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00134875

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:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone

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:

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

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Naloxone
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010