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

University of Colorado, Denver

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Heroin Dependence Opioid-Related Disorders

Interventions

Heroin DependenceDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Colorado Health Sciences Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Drug use

Retention

Subjective dose estimate

Observed withdrawal rating

Opioid agonist rating

Opioid antagonist rating

Pupil diameter

Compliance

Analog rating scale for drug effects

Drug effect characteristics

Dose order estimate-nurse

Dose order estimate-client

Data from ClinicalTrials.gov

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