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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00604188 |
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.
Condition | Intervention | Phase |
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Opiate Dependence Drug Dependence Substance Dependence |
Drug: Suboxone (SCH 000484) Drug: Subutex (SCH 028444) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users |
Estimated Enrollment: | 310 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active Suboxone: Active Comparator
Subjects receive active Suboxone and branded placebo Subutex to mask which medication the subject is receiving. Subjects receive an 8 mg tablet of active Suboxone and 8 mg tablet of placebo Subutex on Day 1, 16 mg on Day 2, and all subjects receive open label Suboxone from Day 3 to Day 28. Dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
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Drug: Suboxone (SCH 000484)
2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
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Active Subutex: Active Comparator
Subjects receive active Subutex and branded placebo Suboxone to mask which medication the subject is receiving. Subjects receive an 8 mg tablet of active Subutex and 8 mg tablet of placebo Suboxone on Day 1, 16 mg on Day 2, and all subjects receive open label Suboxone from Day 3 to Day 28. Dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
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Drug: Subutex (SCH 028444)
2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days
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Rationale: Once Suboxone becomes available for widespread clinical use, it is anticipated that opioid-dependent patients seeking treatment with buprenorphine will be placed directly onto Suboxone. Two strategies that have had good success for inducting patients onto Suboxone have been developed: 1) a "bridging" procedure in which patients initiate therapy with Subutex and then transfer to Suboxone, and 2) a direct Suboxone induction procedure. However, there have been no controlled studies of direct Suboxone induction, and it is not clear whether using a Subutex-to-Suboxone induction procedure would produce any added clinical benefit for the patient relative to direct Suboxone induction.
This study addresses a post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of induction with Suboxone. Using a prospective, randomized, active-drug-controlled, double-blind and double-dummy design, this study will assess the acceptability and safety of Suboxone in heroin users 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. The dose regimen used during the induction phase of this study is identical to that used in the pivotal efficacy study comparing Suboxone and Subutex (Fudala et al, 2003), which is included in the Suboxone Summary of Product Characteristics. The data collected in this study will include information on the extent of opioid use before treatment initiation.
Two strategies for inducting opioid-dependent patients using short-acting opioids (eg, heroin) onto Suboxone have emerged from published US studies. One involves using Subutex to "bridge" the transition to Suboxone by using Subutex over the first 2 days before transferring directly to Suboxone on the third day. The other involves direct Suboxone induction, in which patients receive Suboxone as the initial dose followed by continued rapid Suboxone dose titration.
In the pivotal efficacy study, opiate-dependent heroin users assigned to either Subutex or Suboxone groups received an induction dose of 8 mg of Subutex (administered as a single 8-mg tablet) on Day 1 and 16 mg of Subutex (administered as two 8-mg tablets) on Day 2. The 109 subjects assigned to Suboxone received 16 mg of Suboxone (administered as two 8-mg tablets) on Day 3, and the 105 subjects assigned to Subutex received 16 mg of Subutex (administered as two 8-mg tablets) on Day 3. The induction schedule used in the pivotal trial, in which a Subutex-to-Suboxone bridging procedure was used, was successful for inducting heroin-dependent patients onto Suboxone, achieving good compliance and resulting in relatively few AEs accounting for treatment discontinuation.
Overall, several large-scale studies using Suboxone as an initial medication have been conducted with good results, and it appears clear that, as was the case in the pivotal study, most patients safely tolerate a total dose of at least 8 mg on the first day of treatment. However, as these studies were not controlled, it remains unclear whether using a Subutex-to-Suboxone induction procedure would produce any added clinical benefit to the patient relative to a direct Suboxone induction procedure. Furthermore, there have been no studies of direct Suboxone induction outside of the United States.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Croatia | |
Investigational Site 15 | Recruiting |
Zagreb, Croatia, 10000 | |
Investigational Site 16 | Recruiting |
Zagreb, Croatia, 10000 | |
Investigational Site 17 | Recruiting |
Rijeka, Croatia, 51000 | |
France | |
Investigational Site 4 | Recruiting |
Nimes Cedex 9, France, 30029 | |
Investigational Site 36 | Recruiting |
Bondy Cedex, France, 93143 | |
Investigational Site 7 | Recruiting |
Clermont-Ferrand Cedex, France, 63003 | |
Investigational Site 6 | Recruiting |
Paris Cedex 14, France, 75674 | |
Investigational Site 5 | Recruiting |
Tours, France, 37000 | |
Italy | |
Investigational Site 27 | Recruiting |
Bologna, Italy | |
Investigational Site 29 | Recruiting |
Pescara, Italy, 65124 | |
Portugal | |
Investigational Site 33 | Recruiting |
Aveiro, Portugal, 3810-176 | |
Investigational Site 34 | Recruiting |
Olhao, Portugal, 8700-414 | |
Investigational Site 35 | Recruiting |
Lisbon, Portugal, 1749-002 | |
Slovenia | |
Investigational Site 10 | Recruiting |
Koper, Slovenia, 6000 | |
Investigational Site 11 | Recruiting |
Piran, Slovenia, 6320 | |
United Kingdom | |
Investigational Site 13 | Recruiting |
Hastings, United Kingdom, TN34 1LY |
Study Director: | Leslie Amass, PhD | Schering-Plough |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05042 |
Study First Received: | January 17, 2008 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00604188 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Buprenorphine Heroin Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Opioid-Related Disorders Naloxone |