Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00218101

Enrollment

Registered

2005-09-22

Start date

2004-05-31

Completion date

2005-03-31

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Related Disorders

Keywords

opioid dependence

Brief summary

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.

Detailed description

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.

Interventions

DRUGBuprenorphine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Substance use	—
medication compliance	—
treatment retention	—

Secondary

Measure	Time frame
Behavioral and psychological measures (measured during the dose reduction phase)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026