SUBOXONE NEWS HIGHLIGHTS
Published Studies Related to Suboxone (Buprenorphine / Naloxone)
Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial. [2008.11.05]
CONTEXT: The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. OBJECTIVE: To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth... CONCLUSIONS: Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00078130.
Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. [2008.07]
Methadone treatment reduces human immunodeficiency virus (HIV) risk, but the effects of primary-care-based buprenorphine/naloxone [generic for Suboxone] on HIV risk are unknown. The purpose of this study was to determine whether primary-care-based buprenorphine/naloxone was associated with decreased HIV risk behavior... We conclude that primary-care-based buprenorphine/naloxone treatment is associated with decreased drug-related HIV risk, but additional efforts may be needed to address sex-related HIV risk when present.
Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. [2008.03]
To examine long-term outcomes with primary care office-based buprenorphine/naloxone [generic for Suboxone] treatment, we followed 53 opioid-dependent patients who had already demonstrated six months of documented clinical stability for 2-5 years. Primary outcomes were retention, illicit drug use, dose, satisfaction, serum transaminases, and adverse events...
A randomized trial of effectiveness and cost-effectiveness of observed versus unobserved administration of buprenorphine-naloxone for heroin dependence. [2007.12]
Aims To compare the effectiveness and cost-effectiveness of unobserved versus observed dosing of patients seeking treatment of heroin dependence.Treatment with close clinical monitoring, but no observation of dosing, was significantly cheaper and therefore significantly more cost-effective.
A stepped care strategy using buprenorphine and methadone versus conventional methadone maintenance in heroin dependence: a randomized controlled trial. [2007.05]
CONCLUSIONS: A stepped treatment of heroin dependence as described here appears equally efficacious compared to optimally delivered methadone maintenance therapy. Together with prior data on the advantageous safety of buprenorphine, this suggests that broad implementation of strategies using buprenorphine as first-line treatment should be considered.
Clinical Trials Related to Suboxone (Buprenorphine / Naloxone)
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphin/Naloxone) in Opioid Dependent Patients on Subutex (Study P05094)(COMPLETED) [Completed]
This study is designed to determine if opioid dependent subjects who are already receiving
Subutex prefer the Suboxone tablet over the Subutex tablet after switching from Subutex to
Suboxone. Subjects who are selected to participate in this study will continue their
prescribed dose of Subutex (buprenorphin 2 to 16 mg daily) for the first two days of the
study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone
(buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5).
The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects
will continue their pre-study prescribed dosage of Subutex.
Treatment of Opioid Dependent Patients With Suboxone: Acceptability and Safety From Real Life Scenario (Study P05603) [Recruiting]
The aim of this post marketing surveillance study is to investigate the retention rate after
12 months of substitution treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid
dependent patients under everyday conditions.
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042) [Recruiting]
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin
users as a replacement therapy for opioid dependency by comparing the clinical response of
subjects who are inducted directly onto Suboxone with that of subjects who are inducted first
to Subutex and then transferred to Suboxone.
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843) [Recruiting]
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (Study P05444) [Recruiting]
The purpose of this study is to evaluate the acceptibility and safety of switching to
buprenorphine/naloxone (Suboxone®) and the effect of the switch on medication dispensing.
Subjects will initiate therapy on Day 1 of the study; dosage will be adjusted between Day 2
to 7. Data will be collected at the end of Weeks 2 and 4, then monthly up to the end of
Month 12.
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