Abuse Potential of Buprenorphine/Naloxone

Opioid-Related Disorders Clinical Trial

Official title:

Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00149539
• Other study ID #: NIDA-08045-7
• Secondary ID: R01-08045-7DPMC
• Status: Terminated
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: January 11, 2017
• Start date: June 2004
• Est. completion date: January 2006

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 is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

Description:

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone.

Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Actively abusing illegal opioids

• Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry

• Meets DSM-IV criteria for opioid dependence

Exclusion Criteria:

• Significant medical problems (e.g., insulin dependent diabetes mellitus)

• Non-substance use psychiatric disorders (e.g., schizophrenia)

• Seeking substance abuse treatment

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover 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 (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate withdrawal		up to one day
Primary	opiate agonist symptoms		up to one day
Primary	physiologic measures		up to one day