Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1 - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Yale University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00023283

Purpose

The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)

Condition	Intervention	Phase
Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous	Drug: Buprenorphine	Phase II

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Self-reported frequency of illicit opioid use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percentage of opioid-negative urine specimens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Maximum number of weeks abstinent from illicit opioids [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:

0

Arms	Assigned Interventions
1: Experimental Standard Medical Management with once-weekly medication dispensing	Drug: Buprenorphine Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing
2: Experimental Standard Medical Management with thrice-weekly medication dispensing	Drug: Buprenorphine Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing
3: Experimental Enhanced Medical Management with thrice-weekly medication dispensing	Drug: Buprenorphine Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing

Detailed Description:

A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study.

Exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023283

Contacts

Contact: Richard Schottenfeld, M.D.

(203)974-7349

richard.schottenfeld@yale.edu

Locations

United States, Connecticut
APT Residential Services Division
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Yale University

Investigators

Principal Investigator:

Richard Schottenfeld, M.D.

Yale University

More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. Epub 2007 Oct 15.

Fiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan LE, O'Connor PG, Schottenfeld RS. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006 Jul 27;355(4):365-74.

Responsible Party:	Yale University School of Medicine ( Richard S. Schottenfeld, MD )
Study ID Numbers:	NIDA-9803-1, R01-9803-1
Study First Received:	August 30, 2001
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00023283 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Heroin Dependence
Narcotic Antagonists
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Opioid-Related Disorders
Buprenorphine

Mental Disorders
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid
Substance Abuse, Intravenous

Additional relevant MeSH terms:

Heroin Dependence
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Substance Abuse, Intravenous

ClinicalTrials.gov processed this record on May 06, 2009