At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
AV411 +1 moredrug
Likely dose
AV411 20 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.
The Safety, Tolerability and Preliminary Efficacy of AV411, a Glial Activation Inhibitor, in Heroin Abusers Under Conditions of Morphine Maintenance and Withdrawal
In Brief
A Phase 2 clinical trial evaluating AV411 and Placebo (PCB) for Opioid-Related Disorders. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartOct 2008
Primary CompletionApr 2010
Study CompletionJun 2012
TodayJul 2026
First PostedJul 28, 2008
Enrollment StartOct 1, 2008
Primary CompletionApr 1, 2010
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.9 years ago
Interventions
AV411drug
Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks
Placebo (PCB)drug
Placebo drug will be administered orally twice a day (BID) for two consecutive weeks