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A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

2014-08-27 03:14:04 | BioPortfolio

Summary

Probuphine an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Opioid Dependency

Intervention

Probuphine, placebo implant, Buprenorphine

Location

David Geffen School of Medicine at UCLA
Los Angeles
California
United States
90025

Status

Recruiting

Source

Titan Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:04-0400

Clinical Trials [1391 Associated Clinical Trials listed on BioPortfolio]

Re-Treatment Study of Probuphine in Opioid Addiction

Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a ...

Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood a...

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood a...

Probuphine Innovations for Clinical Effectiveness (PRINCE)

HITLAB will conduct a crossover study wherein participants will be asked to wear an actigraphy device continuously for 12 weeks. The first four weeks of the study participants will continu...

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

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...

PubMed Articles [3117 Associated PubMed Articles listed on BioPortfolio]

Implantable Buprenorphine (Probuphine) for Maintenance Treatment of Opioid Dependence.

Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial.

Buprenorphine/samidorphan combination (BUP/SAM) is an opioid system modulator being investigated as adjunctive treatment for major depressive disorder. BUP/SAM is a fixed-dose combination of buprenorp...

Characteristics and Prescribing Practices of Clinicians Recently Waivered to Prescribe Buprenorphine for the Treatment of Opioid Use Disorder.

Expanding access to medication-assisted treatment with buprenorphine is a cornerstone of the opioid crisis response; yet, buprenorphine remains underutilized. Research has identified multiple barriers...

Sex differences in opioid use and medical issues during buprenorphine/naloxone treatment.

There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive sam...

Interest in prescribing buprenorphine among resident and attending physicians at an urban teaching clinic.

Opioid use disorders are a major medical and public health concern. Buprenorphine is approved for the treatment of opioid use disorders; however, a shortage of physicians prescribing buprenorphine is ...

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.

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.

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

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.

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