Unit for Addiction Medicine, University of Oslo
Oslo, N-0407, Norway
NCT Number: NCT00521157
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.
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Notify Me19 year and older
All sexes
Interventional
Phase 2 / Phase 3
Oslo, N-0407, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Naltrexone implants 3.2 g (double of 1,6 g)
Other names: Go Medical naltrexone implant
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
Time frame: 6 and 12 months
University of Oslo
Other
Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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