A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)

This study has been completed.

Study NCT00604188 Information provided by Schering-Plough

First Received on January 17, 2008. Last Updated on April 6, 2011 History of Changes

Results First Received: December 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Opiate Dependence Drug Dependence Substance Dependence
Interventions:	Drug: Suboxone (SCH 000484) Drug: Subutex (SCH 028444)

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
188 participants were recruited in this study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
188 participants were randomized in the study; however one did not receive any study medication. Therefore the intent-to-treat (ITT) population was 187 participants.

Reporting Groups

	Description
Direct Suboxone Induction	Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
Subutex-to-Suboxone Induction	Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.

Participant Flow: Overall Study

	Direct Suboxone Induction	Subutex-to-Suboxone Induction
STARTED	93	95 ^[1]
COMPLETED	66	70
NOT COMPLETED	27	25
Adverse Event	1	4
Lost to Follow-up	17	15
Withdrawal by Subject	5	1
Non-compliance with protocol	4	4
Did not receive study drug	0	1

[1]	The ITT population for Subutex-to-Suboxone Induction is 94 participants

Baseline Characteristics

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Reporting Groups

	Description
Direct Suboxone Induction	Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
Subutex-to-Suboxone Induction	Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.

Baseline Measures

	Direct Suboxone Induction	Subutex-to-Suboxone Induction	Total
Number of Participants [units: participants]	93	94	187
Age [units: years] Mean ± Standard Deviation	31 ± 8.4	30.5 ± 8.2	30.7 ± 8.3
Gender [units: participants]
Female	21	25	46
Male	72	69	141

Outcome Measures

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1. Primary:

Responders at Day 3 [ Time Frame: 3 days ]

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2. Secondary:

Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS) [ Time Frame: 28 days ]

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3. Secondary:

Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI) [ Time Frame: Days 3 to 28 ]

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4. Secondary:

Self-reported Opioid Withdrawal Symptoms (SOWS) [ Time Frame: Baseline and 28 days ]

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5. Secondary:

Observer-rated Opioid Withdrawal Symptoms (OOWS) [ Time Frame: Baseline and 28 days ]

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6. Secondary:

Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric [ Time Frame: Baseline and 28 days ]

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7. Secondary:

Compliance Rate [ Time Frame: 28 days ]

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8. Secondary:

Responders at Day 28 [ Time Frame: 28 days ]

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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: The disclosure restriction on the PI cannot publish an individual study until a publication disclosing results from multicenter studies is published. 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 45 days from the time submitted to the sponsor for review.

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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided by Schering-Plough

Publications automatically indexed to this study:

Amass L, Pukeleviciene V, Subata E, Almeida AR, Pieri MC, D'Egidio P, Stankova Z, Costa A, Smyth BP, Sakoman S, Wei Y, Strang J. A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. Addiction. 2012 Jan;107(1):142-51. Epub 2011 Oct 12.

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00604188 History of Changes
Other Study ID Numbers:	P05042
Study First Received:	January 17, 2008
Results First Received:	December 7, 2010
Last Updated:	April 6, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency