Naltrexone Implants as Relapse Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Dependency

Keywords

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Substance abuse Treatment Relapse prevention opioid antagonist

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Implantation of naltrexone implants

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Institute of Psychiatry, University of Oslo

Principal Investigators

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Helge Waal, professor

Role: STUDY_DIRECTOR

Unit for addiction medicine, Institute of psychiatry, University of Oslo

Countries

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Norway

References

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Kunoe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen O, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9. doi: 10.1111/j.1360-0443.2010.03031.x.

Reference Type DERIVED

PMID: 20707781 (View on PubMed)

Other Identifiers

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11899

Identifier Type: -

Identifier Source: org_study_id