NCT00521157

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

2.4 years

First QC Date

August 24, 2007

Last Update Submit

May 4, 2009

Conditions

Opiate Dependence

Keywords

Substance abuseOpiate dependencyTreatmentRelapse prevention

Outcome Measures

Primary Outcomes (3)

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

    6 and 12 months

  • Days in work or education

    6 and 12 months

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

    6 and 12 months

Secondary Outcomes (2)

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

    6 and 12 months

  • Quality of life at 6 (12) months by EuropASI

    6 and 12 months

Study Arms (2)

intervention

EXPERIMENTAL

Experimental group randomised after abstinence oriented treatment

Drug: Go Medical Naltrexone implants

2

NO INTERVENTION

waiting list control

Interventions

Go Medical Naltrexone implantsDRUG

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

Also known as: Go Medical naltrexone implant
intervention

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

Study Sites (1)

Unit for Addiction Medicine, University of Oslo

Oslo, N-0407, Norway

Location

Related Publications (2)

  • Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

    PMID: 40342086DERIVED

  • 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

Opioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Helge Waal, Professor

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

    STUDY DIRECTOR

  • Helge Waal, MD

    Norwegian Medical Association

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

NO(1)