Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

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Status and phase: Withdrawn; Phase 2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

NCT00000326

NIDA-11160-1

R01-11160-1

1R01DA011160 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Full description

Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individuals must be currently opioid 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.