Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence

Opioid-Related Disorders Clinical Trial

Official title:

The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134888
• Other study ID #: NIDA-08045-2
• Secondary ID: R01-08045-2DPMC
• Status: Completed
• Phase: N/A
• First received: August 23, 2005
• Last updated: January 11, 2017
• Start date: December 2000
• Est. completion date: November 2002

Study information

• Verified date: July 2007
• 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, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.

Description:

Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.

This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Meets diagnostic criteria for opioid dependence

• Qualifies for opioid substitution treatment (e.g., methadone)

Exclusion Criteria:

• Significant psychiatric or physical disorder

Study Design

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone

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		up to one day
Primary	drug effects (measured at Week 11)		up to one day