CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
buprenorphine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01136356
NCT01136356Phase 2Completed

A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Johns Hopkins University·interventional·Posted Jun 3, 2010·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating buprenorphine and morphine for Opioid Abuse and Opioid Dependence. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2010
Enrollment StartJul 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.1 years ago

Interventions

buprenorphinedrug

parenteral buprenorphine may be administered at multiple times each day

morphinedrug

parenteral morphine may be administered multiple times each day