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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lars Tanum
• Collaborators: Haukeland University Hospital; Hospital of Southern Norway Trust; The Hospital of Vestfold
• Treatments: Analgesics, Opioid; Naltrexone

Criteria

Inclusion Criteria:

-.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

Exclusion Criteria:

• 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