Status:
COMPLETED
Buprenorphine Naltrexone-P1 A-Cocaine
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine-related Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 st...
Eligibility Criteria
Inclusion
- 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
- please contact site for more information
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00733720
Start Date
August 1 2008
End Date
January 1 2009
Last Update
January 12 2017
Active Locations (1)
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1
Drug Dependence Research Center
San Francisco, California, United States, 94143