Buprenorphine as a Treatment in Opiate Dependent Pain Patients

This study has been terminated.

( "Tapering doses" protocol arm was not effective for treatment retention outcome. )

Study NCT00552578 Information provided by State University of New York at Buffalo

First Received on November 1, 2007. Last Updated on February 14, 2011 History of Changes

Results First Received: January 21, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Opiate Addiction Refractory Pain
Intervention:	Drug: buprenorphine/naloxone

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 participants recruited Dec 2007 to Apr 2008

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
Tapering Doses of Buprenorphine	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Steady Dose of Buprenorphine	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.

Participant Flow: Overall Study

	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine
STARTED	6	6
COMPLETED	5	5
NOT COMPLETED	1	1
Lost to Follow-up	1	1

Baseline Characteristics

Reporting Groups

	Description
Tapering Doses of Buprenorphine	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Steady Dose of Buprenorphine	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.

Baseline Measures

	Tapering Doses of Buprenorphine	Steady Dose of Buprenorphine	Total
Number of Participants [units: participants]	6	6	12
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	6	12
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	44 ± 6	46 ± 15	45 ± 11
Gender [units: participants]
Female	4	2	6
Male	2	4	6
Region of Enrollment [units: participants]
United States	6	6	12

Outcome Measures

1. Primary:

Relapse to Substance Abuse [ Time Frame: Six months ]

Show Outcome Measure 1

2. Secondary:

Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. [ Time Frame: Baseline and six months ]

Show Outcome Measure 2

3. Secondary:

Treatment Retention. [ Time Frame: Six months ]

Show Outcome Measure 3

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: R Blondell
Organization: SUNY Buffalo
phone: 716-898-4971
e-mail: blondell@buffalo.edu

Publications of Results:

Responsible Party:	Richard D. Blondell, SUNYBuffalo, Dept Family Medicine
ClinicalTrials.gov Identifier:	NCT00552578 History of Changes
Other Study ID Numbers:	FMD0400907A
Study First Received:	November 1, 2007
Results First Received:	January 21, 2009
Last Updated:	February 14, 2011
Health Authority:	United States: Institutional Review Board