Abuse Potential of Buprenorphine/Naloxone
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone|
- Opiate withdrawal [ Time Frame: up to one day ]
- opiate agonist symptoms [ Time Frame: up to one day ]
- physiologic measures [ Time Frame: up to one day ]
|Study Start Date:||June 2004|
|Study Completion Date:||January 2006|
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.
|United States, Maryland|
|Johns Hopkins University (BPRU) Bayview Campus|
|Baltimore, Maryland, United States, 21224 6823|
|Principal Investigator:||Eric C. Strain, MD||Johns Hopkins University|