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Completed

NCT Number: NCT00521157

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

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Unit for Addiction Medicine, University of Oslo

Oslo, N-0407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Go Medical Naltrexone implants

Drug

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

Other names: Go Medical naltrexone implant

Primary outcomes

  1. Drug use at 6 (12) months by self report and hair analysis

    Time frame: 6 and 12 months

  2. Days in work or education

    Time frame: 6 and 12 months

  3. Number of drug-free friends at 6 (12) months by self report

    Time frame: 6 and 12 months

Secondary outcomes

  1. Depression at 6 (12) months by BDI and Hopkins SCL-25

    Time frame: 6 and 12 months

  2. Quality of life at 6 (12) months by EuropASI

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 27, 2007
Registry last updated
May 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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