Buprenorphine Naltrexone-P1 A-Cocaine
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders
Intervention: Suboxone (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Overall contact:
Reese T Jones, M.D., Phone: 415-476-7452
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.
Clinical Details
Official title: Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Primary outcome: Opioid Effects of study drug
Secondary outcome: Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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:
- please contact site for more information
Locations and Contacts
Reese T Jones, M.D., Phone: 415-476-7452
Drug Dependence Research Center, San Fransisco, California 94143, United States; Recruiting
Reese T Jones, M.D., Phone: 415-476-7452
Lori D Karan, M.D., Phone: 415-476-7491
Reese T. Jones, M.D., Principal Investigator
Additional Information
Starting date: August 2008
Last updated: November 4, 2008
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