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

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ClinicalTrials.gov Identifier: NCT03647774
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Haukeland University Hospital
Hospital of Southern Norway Trust
The Hospital of Vestfold
Information provided by (Responsible Party):
Lars Tanum, University Hospital, Akershus

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Extended release naltrexone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Acting Naltrexone for Opioid Addiction: the Importance of Mental, Physical and Societal Factors for Sustained Abstinence and Recovery
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Extended release naltrexone
Extended release naltrexone 380 mg as an intramuscular injection every 4 weeks.
Drug: Extended release naltrexone
380mg injectable extended release naltrexone every four weeks
Other Name: Vivitrol

No Intervention: Treatment As Usual (TAU)
Daily sublingual buprenorphine in flexibel dose according to the patients need and ART guidelines.



Primary Outcome Measures :
  1. Perceived change in recovery [ Time Frame: 52 weeks ]
    Change in recovery assessed by the XR-NTX participant and by their social workers using interview, compared with controls and their social workers.


Secondary Outcome Measures :
  1. Use of illicit substances [ Time Frame: 52 weeks ]
    Days of use of illicit opioids and other illicit substances in XR-NTX participants using time-line follow-back every 4th week.

  2. Retention in the study [ Time Frame: 52 weeks ]
    Number of weeks the participants stay in the XR-NTX study (retention)

  3. Craving for heroin [ Time Frame: 52 weeks ]
    Change in craving for heroin in XR-NTX participants using a 100 mm VAS scale, where 0 is no craving and 100 is Maximum craving.

  4. Treatment satisfaction [ Time Frame: 52 weeks ]
    Treatment satisfaction among XR-NTX participants using a 100 mm VAS scale, where 0 is absolutely not satisfactory and 100 is full satisfaction with treatment.

  5. Economic cost analyses [ Time Frame: 2 years ]
    Economic cost analyses across health, community, and criminal justice domains on participants receiving XR-NTX compared to the control group

  6. Change in mental health status [ Time Frame: 52 weeks ]
    Assessment mental health status in participants receiving XR-NTX and controls , measured by the Hopkins`Symptom Check List - 25, a 4-point scale assessing mental distress, 15 depression related items and 10 anxiety related items.

  7. Perceived change in quality of life [ Time Frame: 52 weeks ]
    Change in quality of life assessed by the XR-NTX participant and Controls using the World Health Organization Quality of Life Scale - BREF version, a 24 questions that measure four dimentions of quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647774


Contacts
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Contact: Lars Tanum, MD, PhD +4793202038 lars.tanum@ahus.no
Contact: Kristin K Solli, MSci, PhD +4747905895 k.k.solli@medisin.uio.no

Locations
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Norway
Akershus University Hospital Recruiting
Loerenskog, Akershus, Norway, 1478
Contact: Lars Tanum, MD, PhD         
Sponsors and Collaborators
Lars Tanum
Haukeland University Hospital
Hospital of Southern Norway Trust
The Hospital of Vestfold
Investigators
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Principal Investigator: Lars Tanum, MD, PhD University Hospital, Akershus

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Responsible Party: Lars Tanum, Head of Research Unit, R&D dept.in Mental Health, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03647774     History of Changes
Other Study ID Numbers: 2017-004706-18
269864 ( Other Grant/Funding Number: The Research Council of Norway )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Lars Tanum, University Hospital, Akershus:
Extended release naltrexone
Opioid dependence
Recovery
Health economics

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists