CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
injectable naltrexone and dronabinol +1 moredrug
Likely dose
injectable naltrexone and dronabinol 380 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/NCT01024335
NCT01024335Phase 3Completed

Dronabinol Naltrexone Treatment for Opioid Dependence

New York State Psychiatric Institute·interventional·Posted Dec 2, 2009·Updated Jun 18, 2018

In Brief

A Phase 3 clinical trial evaluating injectable naltrexone and dronabinol and Naltrexone and placebo for Opioid Dependence. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.6 years ago

Interventions

injectable naltrexone and dronabinoldrug

Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.

Naltrexone and placebodrug

Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.