NCT00269607

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2005

Enrollment Period

1.6 years

First QC Date

December 22, 2005

Last Update Submit

December 10, 2013

Conditions

Opioid Dependency

Keywords

Substance abuseTreatmentRelapse preventionopioid antagonist

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI

Interventions

Implantation of naltrexone implantsDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • soon to complete inpatient treatment for opioid addiction
  • living in southern Norway

You may not qualify if:

  • psychosis / major depression, currently not treated
  • pregnancy
  • liver enzymes: ASAT or ALAT \> threefold above upper boundary
  • maintenance treatment with methadone or buprenorphine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20707781DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Helge Waal, professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 11, 2013

Record last verified: 2005-12