Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence

NCT00134888

Opioid-Related Disorders

COMPLETED NA

Buprenorphine Pharmacology Related to Addiction Treatment - 18

NCT00000236

Opioid-Related Disorders

COMPLETED PHASE2

Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

NCT00134914

Opioid-Related Disorders

COMPLETED NA

Buprenorphine Pharmacology Related to Addiction Treatment - 21

NCT00000239

Opioid-Related Disorders

COMPLETED PHASE2

Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

NCT01841931

Opioid Use Disorder

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification.

This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. All participants will attend weekly clinical management sessions for the duration of the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid-Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buprenorphine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Current opioid analgesic dependence
* History of at least 2 years of oral opiate analgesic use
* Prescribed opioids for chronic pain
* Pain episode of at least 6 months duration within the 5 years prior to study entry
* Available for the duration of the study
* Good general health

Exclusion Criteria

* Currently using any illicit substance
* Meets criteria for alcohol dependence
* History of heroin use
* History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone
* Evidence of current maximal primary pain

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes