Starting Treatment With Agonist Replacement Therapies (START)

PHASE4CompletedINTERVENTIONAL
Enrollment

1,269

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Opiate-related Disorders
Interventions
DRUG

Buprenorphine/naloxone

Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need.

DRUG

Methadone

Participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit.

Trial Locations (9)

11201

Addiction Research & Treatment Corp, Brooklyn

19137

NET Steps, Philadelphia

90016

Matrix Institute, Los Angeles

94102

BAART; Turk Street Clinic, San Francisco

95816

Bi-Valley Medical Clinic INC., Sacramento

97214

CODA-Research, Portland

98134

Evergreen Treatment Services, Seattle

06120

Hartford Dispensary, Hartford

06705

CT Counseling Centers, Waterbury

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of California, Los Angeles

OTHER

NCT00315341 - Starting Treatment With Agonist Replacement Therapies (START) | Biotech Hunter | Biotech Hunter