ong acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery
- Conditions
- Opioid addictionTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-004706-18-NO
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method