Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 2

Conditions: Heroin Dependence; Opioid-Related Disorders

Treatments: Drug: Heroin Dependence

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000327

R01DA011160 (U.S. NIH Grant/Contract)

NIDA-11160-2

R01-11160-2

Details and patient eligibility

About

The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

Full description

Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic

Sex: All

Ages: 18 to 62 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion criteria

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.