Buprenorphine Naltrexone-P1 A-Cocaine

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00733720

First received: August 11, 2008

Last updated: October 8, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	August 11, 2008
Last Updated Date	October 8, 2009
Start Date ^ICMJE	August 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 11, 2008)	Opioid Effects of study drug [ Time Frame: daily ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00733720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 11, 2008)	Adverse Events [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Buprenorphine Naltrexone-P1 A-Cocaine
Official Title ^ICMJE	Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Cocaine-Related Disorders
Intervention ^ICMJE	Drug: Suboxone 4/1mg, 8/2mg 16/4mg Other Names: buprenorphine/naloxone Subjects will be maintained on 50mg naltrexone
Study Arm (s)	Active Comparator: 1 Each subject will receive all 3 doses of suboxone and placebo Intervention: Drug: Suboxone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	8
Completion Date	January 2009
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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: please contact site for more information
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00733720
Other Study ID Numbers ^ICMJE	N01DA-6-8867
Has Data Monitoring Committee	Not Provided
Responsible Party	Liza Gorgon, NIDA
Study Sponsor ^ICMJE	National Institute on Drug Abuse (NIDA)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute on Drug Abuse (NIDA)
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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