Opioid Dependency
Conditions
Keywords
Substance abuse, Treatment, Relapse prevention, opioid antagonist
Brief summary
The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants in the naltrexone experimental group are prematched in a pairwise fashion with other patients who do not want a naltrexone implant during the first six months after ending inpatient treatment, but who reiceive treatment as usual (TAU) from the Norwegian healthcare system. The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up. We also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.
Interventions
DRUGImplantation of naltrexone implants
Sponsors
University of Oslo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* soon to complete inpatient treatment for opioid addiction * living in southern Norway
Exclusion criteria
* psychosis / major depression, currently not treated * pregnancy * liver enzymes: ASAT or ALAT \> threefold above upper boundary * maintenance treatment with methadone or buprenorphine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI | — |
Outcome results
None listed