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Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction

Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00521157
Enrollment
56
Registered
2007-08-27
Start date
2006-01-31
Completion date
2008-12-31
Last updated
2009-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Dependence

Keywords

Substance abuse, Opiate dependency, Treatment, Relapse prevention

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 volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study. The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables. The investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.

Interventions

DRUGGo Medical Naltrexone implants

Naltrexone implants 3.2 g (double of 1,6 g)

Sponsors

University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
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

MeasureTime frame
Drug use at 6 (12) months by self report and hair analysis6 and 12 months
Days in work or education6 and 12 months
Number of drug-free friends at 6 (12) months by self report6 and 12 months

Secondary

MeasureTime frame
Depression at 6 (12) months by BDI and Hopkins SCL-256 and 12 months
Quality of life at 6 (12) months by EuropASI6 and 12 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026