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

August 11, 2008
October 8, 2009
August 2008
December 2008   (final data collection date for primary outcome measure)
Opioid Effects of study drug [ Time Frame: daily ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00733720 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Buprenorphine Naltrexone-P1 A-Cocaine
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine-Related Disorders
Drug: Suboxone
4/1mg, 8/2mg 16/4mg
Other Names:
  • buprenorphine/naloxone
  • Subjects will be maintained on 50mg naltrexone
Active Comparator: 1
Each subject will receive all 3 doses of suboxone and placebo
Intervention: Drug: Suboxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733720
N01DA-6-8867
Not Provided
Liza Gorgon, NIDA
National Institute on Drug Abuse (NIDA)
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP