Naltrexone Implants as Relapse Prevention
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by University of Oslo.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Oslo
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00269607
First received: December 22, 2005
Last updated: October 16, 2006
Last verified: December 2005
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 22, 2005 | ||||
| Last Updated Date | October 16, 2006 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00269607 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Naltrexone Implants as Relapse Prevention | ||||
| Official Title ICMJE | Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction. An Observational Study. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Opioid Dependency | ||||
| Intervention ICMJE | Drug: Implantation of naltrexone implants | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Kunøe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen Ø, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00269607 | ||||
| Other Study ID Numbers ICMJE | 11899 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Oslo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Oslo | ||||
| Verification Date | December 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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