Buprenorphine Naltrexone-P1 A-Cocaine - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00733720

Purpose

The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Suboxone	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride 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 Effects of study drug [ Time Frame: daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: Daily ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	8
Study Start Date:	August 2008
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Each subject will receive all 3 doses of suboxone and placebo	Drug: Suboxone 4/1mg, 8/2mg 16/4mg

Eligibility

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

Criteria

Inclusion Criteria:

Provide written informed consent
Be male/female between the ages of 18-55
Be in good physical and mental health as determined by interview and physical exam
Have a body mass index between 18 and 30, inclusive
Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo
Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone
Be able to comply with protocol requirements
If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo

Exclusion Criteria:

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733720

Locations

United States, California
Drug Dependence Research Center
San Fransisco, California, United States, 94143

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

More Information

No publications provided

Responsible Party:	NIDA ( Liza Gorgon )
Study ID Numbers:	N01DA-6-8867
Study First Received:	August 11, 2008
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00733720 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010