Naltrexone Implants as Relapse Prevention
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|ClinicalTrials.gov Identifier: NCT00269607|
Recruitment Status : Terminated (Recruitment difficulties. Reframed as pilot study)
First Posted : December 23, 2005
Last Update Posted : December 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependency||Drug: Implantation of naltrexone implants||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction.|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- 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 Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269607
|Study Director:||Helge Waal, professor||Unit for addiction medicine, Institute of psychiatry, University of Oslo|