Study start date: July 1, 1997Actual date on which the first participant was enrolled.
The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.
S/A brief "Summary for the Public"
Official TitleBuprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
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.
How participants are assigned to different groups/arms In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision. None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments Single-group assignment: Everyone gets the same treatment. Cross-over assignment: Participants switch between treatments during the study. Factorial assignment: Participants receive different combinations of treatments. Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses. Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.
Other Ways to Mask Information Open-label: Everyone knows which treatment is being given. Single-blind: Participants do not know which treatment they are receiving, but researchers do. Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given. Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Heroin Dependence
Opioid-Related Disorders
Criteria
1 inclusion criteria required to participate
ndividuals must be at least 18 years of age, 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
1 exclusion criteria prevent from participating
ndividuals 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
Suspended
University of Colorado Health Sciences CenterDenver, United StatesSee the location