Completed

Target Dose Range Identification for Buprenorphine/Naloxone Combination Tablet in Low to Moderate Opiate Dependence

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

Data Collection

Who is being recruted

Narcotic-Related Disorders+2

+ Mental Disorders

+ Opioid-Related Disorders

From 21 to 50 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1995
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1995

Actual date on which the first participant was enrolled.

This study focuses on finding the right dose range of a medication called buprenorphine/naloxone combination tablet that can help individuals with low to moderate opiate addiction. The goal is to provide relief without causing dependence. The study is important as it aims to find an appropriate starting dose for treatment, potentially improving care for those struggling with opiate addiction. Participants in this study will receive the buprenorphine/naloxone combination tablet. The study measures the effectiveness of the treatment by evaluating opiate cravings, opiate use, and withdrawal symptoms. The aim is to find a balance where the medication reduces cravings and withdrawal symptoms without leading to further dependence.

Official TitleBuprenorphine Combination Tablet Feasibility
NCT00000298
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 27, 2026
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 21 to 50 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 DisordersOpioid-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

4 inclusion criteria required to participate
Opiate dependence according to DSM-IV criteria

Self-reported use within the last 30 days

Agreeable to conditions of study and signed informed consent

Males/Females ages 21-50

6 exclusion criteria prevent from participating
Psychiatric disorder that requires medication therapy

History of seizures

Pregnant and/or nursing women

Dependence on etoh or benzodiazepines or other sedative-hypnotics

Show More Criteria

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

Friends Research Institute

Los Angeles, United StatesOpen Friends Research Institute in Google Maps
CompletedOne Study Center