Prescription Opioid Addiction Treatment Study (POATS) - Full Text View

Sponsor:	Mclean Hospital
Collaborator:	University of California, Los Angeles
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00316277

Purpose

The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.

Condition	Intervention	Phase
Opiate Dependence Substance-Related Disorders Opioid-Related Disorders	Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence

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

Primary Outcome Measures:

Opiate abstinence [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Withdrawal symptoms [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Craving symptoms [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Reduction in drug use [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Effect of pain in determining or mediating the response to EMM [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Frequency and nature of adverse events and serious adverse events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	653
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2012
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Buprenorphine/Nx with EMM: Experimental	Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
Buprenorphine/Nx with SMM: Active Comparator	Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.

Arms

Assigned Interventions

Buprenorphine/Nx with EMM: Experimental

Behavioral: Enhanced Medical Management (EMM) of Prescription Opiate Abuse

Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.

Buprenorphine/Nx with SMM: Active Comparator

Behavioral: Standard Medical Management (SMM) of Prescription Opiate Abuse

Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.

Detailed Description:

This is a randomized 2-phase, open-label; multi-center study conducted in outpatient treatment settings. The main objective of this study is to identify an effective sublingual buprenorphine/naloxone treatment regimen for subjects dependent on prescription opioids. Phase 1 of this study will assess the prevailing one-month detoxification practice. This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm. The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphine/naloxone treatment. There is also a long-term follow-up assessment to determine outcomes at 1.5 years, 2.5 years, and 3.5 years after treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years old or older
Physically dependent on opioids
Meet DSM-IV criteria for opioid dependence

Exclusion Criteria:

Known allergy or sensitivity to buprenorphine or naloxone
Unstable psychiatric disorder
Pregnant or lactating females
Liver function test results greater than 5 times the upper limit of normal range

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316277

Locations

United States, California
Integrated Substance Abuse Programs
Los Angeles, California, United States, 90025
San Francisco General Hospital
San Francisco, California, United States, 94110
United States, Indiana
East Indiana Treatment Center
Lawrenceburg, Indiana, United States, 47025
United States, Massachusetts
McLean Hospital, Alcohol and Drug Abuse Treatment Program
Belmont, Massachusetts, United States, 02478
United States, New York
North Shore - Long Island Jewish Health Systems
Glen Oaks, New York, United States, 11004
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
Bellevue Hospital Center
New York, New York, United States, 10016
United States, Oregon
ADAPT, Inc.
Roseburg, Oregon, United States, 97470
United States, South Carolina
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671
United States, Texas
Homeward Bound, Inc.
Dallas, Texas, United States, 75208
United States, Washington
Providence Behavioral Health Service
Everett, Washington, United States, 98206
United States, West Virginia
Chestnut Ridge Hospital
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mclean Hospital

University of California, Los Angeles

Investigators

Principal Investigator:	Roger Weiss, M.D.	Mclean Hospital
Principal Investigator:	Walter Ling, M.D.	University of California, Las Angeles

More Information

No publications provided

Responsible Party:	Mclean Hospital/Harvard Medical School ( Roger Weiss, M.D. )
Study ID Numbers:	NIDA-CTN-0030
Study First Received:	April 18, 2006
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00316277 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Opiate Analgesic Dependence

Additional relevant MeSH terms:

Pathologic Processes
Disease
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

ClinicalTrials.gov processed this record on November 20, 2009