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Long Acting Naltrexone for Opioid Addiction: Focus on Sustained Abstinence and Recovery

NCT03647774 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2022-12-02

No results posted yet for this study

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.

Conditions

  • Opioid-use Disorder

Interventions

DRUG

Extended release naltrexone

380mg injectable extended release naltrexone every four weeks

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • Hospital of Southern Norway Trust

    collaborator OTHER

  • The Hospital of Vestfold

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Lars Tanum

    lead OTHER

Principal Investigators

  • Lars Tanum, MD, PhD · University Hospital, Akershus

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-10-13
Completion
2022-10-13
FDA Drug
Yes

Countries

  • Norway

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03647774 on ClinicalTrials.gov