Opioid addiction
Conditions
Interventions
Trade Name: Vivitrol
Product Name: Vivitrol (Extended-release naltrexone hydrochloride for extended-release injectable suspension)
Product Code: N07BB04
Pharmaceutical Form: Injection
INN or Proposed
Sponsors
Akershus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Male or female at 18-65 years 3. 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) 4. Is voluntarily seeking treatment for opioid dependence 5. Completing a stay in a controlled environment with restricted access to substances of abuse with a minimum duration of 7 (seven) days (waived for OMT controls) 6. 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. 7. If female and of childbearing potential, must agree to use an highly effective acceptable method of contraception for the duration of the study (waived for OMT controls) 8. Capable of understanding and complying with the study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding 2. 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)) 3. Severe psychiatric disorder (including: current or recurrent affective disorders with suicidal behavior, psychotic disorders) that need medical attention and follow-up 4. 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) 5. 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). 6. Alcoholism defined by the criteria in DSM V 7. Serious respiratory debilitation. 8. Any finding that in the view of the PI would compromise the subject’s ability to fulfill the protocol visit schedule or visit requirements 9. Employment by Alkermes or Reckitt-Benckiser or Curida AS (permanent, temporary contract worker, or designee responsible for the conduct of the study) or immediate family of an Alkermes or Reckitt-Benckiser or Curida employee. 10. Abnormal laboratory assessments. If pathological values, coordinating investigator will decide if the subject is eligible for participation in the study 11. Not participating in any other trial that might affect the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Additional main objective during the study 5. To measure physiological and behavioural responses to stimuli known to be modulated by the brain’s opioid system such as social stressors, physical pain and rewards. Additional main objectives at week 26 and week 52 after treatment discontinuation 6. Participants current use of illicit substances 26 weeks and 52 weeks after the end of XR-NTX treatment, based on interview 7. Participants current social situation including employment, housing and familial status 26 weeks and 52 weeks after end of XR-NTX treatment, based on interview ;Secondary Objective: Updating of objective to include additional monitoring of adverse events after end of treatment 4. To explore the frequency and type of adverse events of XR-NTX treatment from baseline to week 52. Adverse events will also be monitored up to 12 months after end of treatment. Additional Secondary objectives for WP1, WP2, WP3 and WP4 (24 +28 week study) 13. To explore the post-treatment efficacy of NTX on the current use of illicit substances and social status including employment, housing and familial situation of the participants at 26 weeks and 52 weeks after study termination. 14. To collect and analyse data on personality and history of adverse events during childhood that may also be important predictors for adherence to treatment. ;Primary end point(s): Additional Primary Endpoints at week 26 and week 52 after treatment discontinuation 6. Participants current use of illicit substances 26 weeks and 52 weeks after the end of XR-NTX treatment, based on interview 7. Participants current social situation including employment, housing and familial status 26 weeks and 52 weeks after end of XR-NTX treatment, based on interview;Timepoint(s) of evaluation of this end point: 26 and 52 weeks after treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional Secondary Endpoints at week 24 and week 52 14. Personality traits and experience of childhood adversity Other secondary endpoints: recovery relevant outcomes: 6. Death during the study or after end of treatment (Correction in point 6 from end of study to end of treatment);Timepoint(s) of evaluation of this end point: 24 and 52 weeks | — |
Countries
Norway
Contacts
Public ContactDivision Mental Health Services
Akershus University Hospital
Outcome results
None listed