Prescription Opioid Addiction Treatment Study (POATS)

PHASE3CompletedINTERVENTIONAL
Enrollment

653

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

July 31, 2009

Study Completion Date

January 31, 2013

Conditions
Opiate DependenceSubstance-related DisordersOpioid-related Disorders
Interventions
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.

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.

Trial Locations (12)

10016

Bellevue Hospital Center, New York

10019

St. Luke's Roosevelt Hospital Center, New York

11004

North Shore - Long Island Jewish Health Systems, Glen Oaks

26505

Chestnut Ridge Hospital, Morgantown

29671

Behavioral Health Services of Pickens County, Pickens

47025

East Indiana Treatment Center, Lawrenceburg

75208

Homeward Bound, Inc., Dallas

90025

Integrated Substance Abuse Programs, Los Angeles

94110

San Francisco General Hospital, San Francisco

97470

ADAPT, Inc., Roseburg

98206

Providence Behavioral Health Service, Everett

02478

McLean Hospital, Alcohol and Drug Abuse Treatment Program, Belmont

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

lead

Mclean Hospital

OTHER

NCT00316277 - Prescription Opioid Addiction Treatment Study (POATS) | Biotech Hunter | Biotech Hunter