Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Heroin Dependence

Drug
Who is being recruted

Narcotic-Related Disorders+3

+ Mental Disorders

+ Chemically-Induced Disorders

From 18 to 62 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1997
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: May 4, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1997

Actual date on which the first participant was enrolled.

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

NCT00000327
Principal SponsorUniversity of Colorado, Denver
Last updated: May 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 62 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersMental DisordersChemically-Induced DisordersHeroin DependenceOpioid-Related DisordersSubstance-Related Disorders

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Colorado Health Sciences Center

Denver, United StatesOpen University of Colorado Health Sciences Center in Google Maps
SuspendedOne Study Center