Clinical trial NCT00521157: Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction
Official title: Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Opiate Dependence
Keywords: Substance abuse
Opiate dependency
Treatment
Relapse prevention
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2007-08-27
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Drug use at 6 (12) months by self report and hair analysis
timeFrame: 6 and 12 months
measure: Days in work or education
timeFrame: 6 and 12 months
measure: Number of drug-free friends at 6 (12) months by self report
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Depression at 6 (12) months by BDI and Hopkins SCL-25
timeFrame: 6 and 12 months
measure: Quality of life at 6 (12) months by EuropASI
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Unit for Addiction Medicine, University of Oslo
Study officials:
affiliation: Unit for addiction medicine, Institute of psychiatry, University of Oslo
name: Helge Waal, Professor
role: STUDY_DIRECTOR
affiliation: Norwegian Medical Association
name: Helge Waal, MD
role: STUDY_DIRECTOR
References:
citation: 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.