Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction

NCT ID: NCT00521157

Last Updated: 2009-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Opiate Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

Experimental group randomised after abstinence oriented treatment

Group Type: EXPERIMENTAL

Go Medical Naltrexone implants

Intervention Type: DRUG

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

2

waiting list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Go Medical Naltrexone implants

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

Intervention Type: DRUG

Other Intervention Names

Go Medical naltrexone implant

Eligibility Criteria

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

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Institute of Psychiatry, University of Oslo

Principal Investigators

Helge Waal, Professor

Role: STUDY_DIRECTOR

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

Helge Waal, MD

Role: STUDY_DIRECTOR

Norwegian Medical Association

Locations

Unit for Addiction Medicine, University of Oslo

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 40342086 (View on PubMed)

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

11899 revised

Identifier Type: -

Identifier Source: org_study_id