CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 317 enrolled
Drug / intervention
Extended release naltrexonedrug
Likely dose
Extended release naltrexone 380mgfrom 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/NCT03647774
NCT03647774Phase 4Completed
CompareCT.gov

Long Acting Naltrexone for Opioid Addiction: the Importance of Mental, Physical and Societal Factors for Sustained Abstinence and Recovery

Lars Tanum·interventional·Posted Aug 27, 2018·Updated Dec 2, 2022

In Brief

A Phase 4 clinical trial evaluating Extended release naltrexone for Opioid-use Disorder. Completed, enrolled 317 participants across 1 site.

Detailed Summary

This study is designed as an open-label evaluation of how treatment with XR-NTX may influence the quality and speed of recovery of opioid dependent individuals - in a context of a naturalistic clinical treatment of opioid dependence. The study will assess recovery outcomes and compare these with the clinical effectiveness of XR-NTX (use of illicit substances and safety). Further, the study will assess the recovery outcomes in matched controls receiving treatment with buprenorphine or buprenorphine-naloxone and enrolled in the national OMT program, and compare this with participants receiving XR-NTX.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-use Disorder
CountriesNorway
CollaboratorsHaukeland University Hospital, Hospital of Southern Norway Trust, The Hospital of Vestfold, Oslo University Hospital

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 27, 2018
Enrollment StartAug 1, 2018
Primary CompletionOct 13, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.8 years ago

Interventions

Extended release naltrexonedrug

380mg injectable extended release naltrexone every four weeks