Buprenorphine Naltrexone-P1 A-Cocaine
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/13/2017 |
| Start Date: | August 2008 |
| End Date: | January 2009 |
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.
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.
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
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