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

NCT03647774 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: 2017-004706-18269864
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Extended release naltrexone; Opioid dependence; Recovery; Health economics

Outcome Measures

Primary Outcomes (1)

• Perceived change in recovery

  Change in recovery assessed by the XR-NTX participant and by their social workers using interview, compared with controls and their social workers.

  52 weeks

Secondary Outcomes (7)

• Use of illicit substances

  52 weeks

• Retention in the study

  52 weeks

• Craving for heroin

  52 weeks

• Treatment satisfaction

  52 weeks

• Economic cost analyses

  2 years

Study Arms (2)

Extended release naltrexone

EXPERIMENTAL

Extended release naltrexone 380 mg as an intramuscular injection every 4 weeks.

Drug: Extended release naltrexone

Treatment As Usual (TAU)

NO INTERVENTION

Daily sublingual buprenorphine in flexibel dose according to the patients need and ART guidelines.

Interventions

Extended release naltrexone DRUG

380mg injectable extended release naltrexone every four weeks

Also known as: Vivitrol

Extended release naltrexone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
• Male or female at 18-65 years
• Has a current diagnosis of opioid dependence, based on the criteria of the DSM-V (304.00) as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
• Is voluntarily seeking treatment for opioid dependence
• Completing a stay in a controlled environment with restricted access to substances of abuse with a minimum duration of seven days (waived for OMT controls)
• Is enrolled in the Norwegian national opioid maintenance treatment (OMT) program 'LAR' before discharge from a controlled environment. For subjects who complete \& submit their LAR application while in a controlled environment, the investigator may complete enrolment data collection while awaiting response on LAR admission.
• If female and of childbearing potential, must agree to use ahighly effective method of contraception for the duration of the study (waived for OMT controls)
• Capable of understanding and complying with the study procedures

You may not qualify if:

• Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding
• Clinically significant medical condition or observed abnormalities that need medical attention and follow-up (including: severe hepatic (Child-Turcotte-Pugh level C) or renal failure, clinically significant symptoms of progressive Acquired Immunodeficiency Syndrome (AIDS))
• Severe psychiatric disorder (including: current or recurrent affective disorders with suicidal behavior, psychotic disorders) that need medical attention and follow-up
• Use of any excluded medication at screening or anticipated/required use during the study period (including: requiring treatment with opioid medications other than investigational products) (waived for OMT controls)
• Known intolerance and/or hypersensitivity to XR-NTX, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluent (waived for OMT controls).
• Alcoholism defined by the criteria in DSM V
• Serious respiratory debilitation.
• Any finding that in the view of the PI would compromise the subject's ability to fulfill the protocol visit schedule or visit requirements
• Employment by Alkermes or Reckitt-Benckiser (permanent, temporary contract worker, or designee responsible for the conduct of the study) or immediate family of an Alkermes or Reckitt-Benckiser employee.
• Abnormal laboratory assessments. If pathological values, coordinating investigator will decide if the subject is eligible for participation in the study
• Not participating in any other trial that might affect the current study

Sponsors & Collaborators

• Lars Tanum: lead
• Haukeland University Hospital: collaborator
• Hospital of Southern Norway Trust: collaborator
• The Hospital of Vestfold: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Loerenskog, Akershus, 1478, Norway

Location

Related Publications (3)

• Juya F, Klemmetsby Solli K, Sannes AC, Weimand B, Gjerstad J, Tanum L, Mordal J. Genetic Influence on Extended-Release Naltrexone Treatment Outcomes in Patients with Opioid Use Disorder: An Exploratory Study. Brain Sci. 2025 Dec 24;16(1):23. doi: 10.3390/brainsci16010023.

  PMID: 41594744 DERIVED

• Mordal J, Juya F, Holtan L, Vederhus JK, Opheim A, Brenna IH, Enger AE, Weimand B, Solli KK, Tanum L. High induction rate onto extended-release naltrexone for people with opioid use disorder: experiences from a Norwegian naturalistic study. Addict Sci Clin Pract. 2025 Jun 16;20(1):50. doi: 10.1186/s13722-025-00576-9.

  PMID: 40524244 DERIVED

• Marciuch A, Brenna IH, Weimand B, Solli KK, Tanum L, Rostad BK, Birkeland B. Patients' experiences of continued treatment with extended-release naltrexone: a Norwegian qualitative study. Addict Sci Clin Pract. 2022 Jul 18;17(1):36. doi: 10.1186/s13722-022-00317-2.

  PMID: 35850782 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lars Tanum, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research Unit, R&D dept.in Mental Health

Model Details: A multicenter, open-label treatment study. Extended-release naltrexone hydrochloride injectable suspension (Vivitrol®) (later referred to as XR-NTX) 380 mg/4 weeks One control group enrolled in the national ART program receives "treatment as usual"; flexible dose of daily oral buprenorphine or buprenorphine-naloxone in line with the clinical guidelines in Norway

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 27, 2018
• Study Start: August 1, 2018
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)