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
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Drug: Extended release naltrexone||Phase 4|
Show Detailed Description
|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.
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
|Contact: Lars Tanum, MD, PhDfirstname.lastname@example.org|
|Contact: Kristin K Solli, MSci, PhDemail@example.com|
|Akershus University Hospital||Recruiting|
|Loerenskog, Akershus, Norway, 1478|
|Contact: Lars Tanum, MD, PhD|
|Principal Investigator:||Lars Tanum, MD, PhD||University Hospital, Akershus|