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Abuse Potential of Buprenorphine/Naloxone

2014-07-24 14:28:49 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Opioid-Related Disorders

Intervention

Buprenorphine/naloxone

Location

Johns Hopkins University (BPRU) Bayview Campus
Baltimore
Maryland
United States
21224 6823

Status

Terminated

Source

National Institute on Drug Abuse (NIDA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:28:49-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

Disorders related or resulting from abuse or mis-use of opioids.

An opioid antagonist with properties similar to those of NALOXONE; in addition it also possesses some agonist properties. It should be used cautiously; levallorphan reverses severe opioid-induced respiratory depression but may exacerbate respiratory depression such as that induced by alcohol or other non-opioid central depressants. (From Martindale, The Extra Pharmacopoeia, 30th ed, p683)

Medical treatment for opioid dependence using a substitute opiate such as METHADONE or BUPRENORPHINE.

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