Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.
This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.
Primary Purpose: Treatment
National Institute on Drug Abuse (NIDA)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00015028
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.
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...
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. Th...
Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihoo...
The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxon...
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or bupr...
To examine awareness of, experience with, and attitudes toward buprenorphine, to begin to understand why opioid users may not access buprenorphine treatment. Factors associated with attitudes toward b...
Deaths related to opioid overdose have increased in the past decade. Community-based pharmacy practitioners have worked toward overcoming logistic and cultural barriers to make naloxone distribution f...
Among agents for treatment of opioid addiction, methadone is a full mu-opioid receptor agonist, whereas buprenorphine is a partial agonist. Both are long-acting. Buprenorphine has a superior safety pr...