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 : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Drug: Extended release naltrexone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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)|
|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|
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.
- 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.
- 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.
- Retention in the study [ Time Frame: 52 weeks ]Number of weeks the participants stay in the XR-NTX study (retention)
- 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.
- 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.
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647774
|Contact: Lars Tanum, MD, PhDemail@example.com|
|Contact: Kristin K Solli, MSci, PhDfirstname.lastname@example.org|
|Akershus University Hospital||Recruiting|
|Loerenskog, Akershus, Norway, 1478|
|Contact: Lars Tanum, MD, PhD|
|Principal Investigator:||Lars Tanum, MD, PhD||University Hospital, Akershus|