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

Study Overview
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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 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.

Official Title
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Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study

Conditions
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Opiate Dependence

Intervention / Treatment
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* Drug: Go Medical Naltrexone implants


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Experimental group randomised after abstinence oriented treatment | Drug: Go Medical Naltrexone implants<br>* Naltrexone implants 3.2 g (double of 1,6 g)<br>* Other names: Go Medical naltrexone implant;|
| No Intervention: 2<br>waiting list control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance abuse, Opiate dependency, Treatment, Relapse prevention