A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

This study has been completed.

Study NCT00605033 Information provided by Reckitt Benckiser Pharmaceuticals, Inc

First Received on January 17, 2008. Last Updated on April 14, 2011 History of Changes

Results First Received: May 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Opiate Dependence Drug Dependence
Interventions:	Drug: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Suboxone	Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Subutex	Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.

Participant Flow: Overall Study

	Suboxone	Subutex
STARTED	143	98 ^[1]
COMPLETED	136	90
NOT COMPLETED	7	8
Adverse Event	2	2
Lost to Follow-up	1	1
Withdrawal by Subject	3	4
Protocol Violation	1	1

[1]	One participant was randomized but withdrew before taking any study medication (treated n=97).

Baseline Characteristics

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Reporting Groups

	Description
Suboxone	Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
Subutex	Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.

Baseline Measures

	Suboxone	Subutex	Total
Number of Participants [units: participants]	143	97	240
Age [units: years] Mean ± Standard Deviation	35.8 ± 8.2	35.5 ± 8.7	35.7 ± 8.4
Gender [units: participants]
Female	30	22	52
Male	113	75	188

Outcome Measures

1. Primary:

Response Rate [ Time Frame: Assessed by Day 7 of double-blind, double-dummy treatment period. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator will publish/present results together with other study sites, unless written permission is obtained from Sponsor. Investigator provides 45 days' written notice to Sponsor prior to submission for publication/presentation so that Sponsor can review copies of abstracts/manuscripts reporting results. Sponsor has the right to review/comment on any presentation regarding proprietary information, accuracy and fair balance of the information, and compliance with FDA regulations.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00605033 History of Changes
Other Study ID Numbers:	P04843, SWITCH
Study First Received:	January 17, 2008
Results First Received:	May 27, 2010
Last Updated:	April 14, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency