A Phase 4 interventional study of Buprenorphine (Subutex) and Buprenorphine/naloxone (Suboxone) in Opioid Dependency, sponsored by Indivior Inc.. Completed at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-30.
Sponsored by Indivior Inc. · Phase 4, Interventional, and Treatment
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries.
Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.
Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.
Indivior Inc. is the lead sponsor of 51 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Buprenorphine (Subutex)
Drug: Buprenorphine/naloxone (Suboxone)
Sublingual tablet
Also known as: Subutex
Sublingual tablet
Also known as: Suboxone
number of study drug injections per week
Time frame: 1 week
Addiction severity
Time frame: 3 months
Withdrawal severity
Time frame: 1 month
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indivior Inc.