Alcohol dependence in outpatients. MedDRA version: 14.1 Level: LLT Classification code 10001640 Term: Alcoholism (excl psychosis) System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: O'Neil Long Acting Naltrexone Implant
Product Code: O'Neil Long Acting Naltrexone Implant
Pharmaceutical Form: Implantation tablet
INN or Proposed INN: Naltrexone
CAS Number: 1650-41-3
C
Sponsors
Oslo University Hospital
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent Alcohol dependence Living in greater Oslo area At least 18 years of age Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Severe psychiatric disease (psychosis, suicidal ideation) Severe liver impairment (chirrhosis) Severe renal impairment Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce risk of relapse to heavy drinking.;Secondary Objective: Increase quality of life. Relate outcomes to genetic variation.;Primary end point(s): first day with heavy drinking (>5 units per day) first day with any drinking Number of days without alcohol consumption;Timepoint(s) of evaluation of this end point: Monthly. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): QoL, gen analyses;Timepoint(s) of evaluation of this end point: Monthly. | — |
Countries
Norway
Contacts
Public ContactNorw. Centre f. Addiction Research
SERAF
Outcome results
None listed