| May 22, 2008 |
| May 23, 2008 |
| July 2007 |
| December 2007 (final data collection date for primary outcome measure) |
| Patient's self assessment using 10 cm visual analogic scale (VAS) of overall preference for one of the two buprenorphine-based maintenance therapies. [ Time Frame: Each treatment Day ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00684073 on ClinicalTrials.gov Archive Site |
- Patient's self assessment using 10-cm visual analogic scale (VASE) of tablet taste, tablet size, sublingual retention time, and well-being over the past 24 hours. [ Time Frame: Each treatment Day ] [ Designated as safety issue: No ]
- Direct questioning of patient's final preference for one of the two buprenorphine-based maintenance therapies and their wish to continue with Suboxone. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphin/Naloxone) in Opioid Dependent Patients on Subutex (Study P05094)(COMPLETED) |
| Evaluation of Preference for a Buprenorphine-Based Maintenance Therapy, After a Switch From Buprenorphine Alone (Subutex®) to the Buprenorphin/Naloxone Combination (Suboxone), in Opioid-Dependent Patients With Buprenorphine Maintenance Therapy |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Open Label, Uncontrolled, Single Group Assignment |
- Opiate-Related Disorders
- Opiate Dependence
- Drug Abuse
|
- Drug: buprenorphine
- Drug: buprenorphine/naloxone
|
| Experimental: Subutex for first two days of study followed by Suboxone for last 3 days of study |
| |
| |
| Completed |
| 60 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Patient must be at least (>=) 18 years of age, of either sex.
- Patient treated for opioid dependence with Subutex® with a stable daily dose between 2 mg and 16 mg daily, for at least 6 months.
- Patient who do not inject/misuse their treatment with Subutex®.
- Patient must be free of illicit opiate drug use as assessed by urine test performed prior to inclusion.
- Patient must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications / products and adverse events to the investigator or designee.
- Women of childbearing potential (includes women who are less than one year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterile (e.g., hysterectomy or tubal ligation).
- Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. Women of childbearing potential must have a urine pregnancy test with negative result within 2 weeks prior to inclusion (as performed under control of the investigator or designee).
Exclusion Criteria:
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00684073 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| P05094, 2006-006686-17 |
| Schering-Plough |
|
|
| Schering-Plough |
| May 2008 |