Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00134914

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

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals

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:

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

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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Eric C. Strain, MD

Johns Hopkins University

More Information

Publications:

Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology (Berl). 2001 Mar;154(3):230-42.

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

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Narcotic Antagonists
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin

Narcotics
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid
Naloxone

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
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 May 07, 2009