CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Buprenorphine +2 moredrug
Likely dose
Buprenorphine 60 mgfrom 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/NCT00460239
NCT00460239Phase 2Completed

Evaluation of Opioid Antagonist Activity in Humans

Johns Hopkins University·interventional·Posted Apr 13, 2007·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating Buprenorphine, Morphine, and 1 other intervention for Opioid-related Disorders. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This is a residential study that looks at the effects of buprenorphine in persons who abuse but are not dependent on opioids. Animal studies show that very high doses of buprenorphine produce less effects than mid-range doses. This suggests that buprenorphine can be a very safe medication. However, no studies in humans have tested higher doses in a similar way. The goal of this study is to show the effects of single doses of buprenorphine, across a range of doses, in persons who are not physically dependent on opioids (but do abuse opioids).

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2007
Enrollment StartJan 1, 2007
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.2 years ago

Interventions

Buprenorphinedrug

Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week.

Morphinedrug

Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind

Placebodrug

Intramuscular; double blind; once per week