NCT00149539

Abuse Potential of Buprenorphine/Naloxone

Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Detailed description

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone. Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone

Timeline

• Start date: 2004-06-01
• Completion: 2006-01-01
• First posted: 2005-09-08
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States