NCT01136356

A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.

Conditions

• Opioid Abuse
• Opioid Dependence

Interventions

Type	Name	Description
DRUG	buprenorphine	parenteral buprenorphine may be administered at multiple times each day
DRUG	morphine	parenteral morphine may be administered multiple times each day

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-06-03
• Last updated: 2017-03-03
• Results posted: 2017-03-03

Locations

1 site across 1 country: United States