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NCT00000243 Clinical Trial

Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone

Opioid-Related Disorders Clinical Trial

Official title:
Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00000243
Other study ID # NIDA-08045-1
Secondary ID R01-08045-1DPMC
Status Terminated
Phase N/A
First received September 20, 1999
Last updated January 11, 2017
Start date September 2002
Est. completion date January 2004

Study information
Verified date November 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.

Description:

Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Meets criteria for opioid dependence

Exclusion Criteria:

- Significant medical or psychiatric illness

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine

Locations
Country Name City State
United States Johns Hopkins University (BPRU) Bayview Campus Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physiological effects
Primary Analog rating scale for drug effects
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