Naltrexone Enhanced Addiction Treatment (NEAT)
Research type
Research Study
Full title
Naltrexone Enhanced Addiction Treatment (NEAT): A randomised controlled trial of the clinical and cost-effectiveness of extended-release naltrexone and oral naltrexone.
IRAS ID
113406
Contact name
John Strang
Contact email
Sponsor organisation
King's College London
Eudract number
2013-002584-25
Research summary
non-medical opioid use disorder (street heroin is the illicit drug targeted by this study) is a persistent and debilitating condition. NHS specialist clinics offer psychological therapy and support to patients who are trying to stay off heroin but relapse rates are high and more effective therapies are sought and recommended by NICE and NIHR. Naltrexone is an opioid antagonist medication which blocks the effects of any consumed heroin and can be a valuable adjunctive therapy for patients to help them maintain abstinence and recover. The standard, oral tablet form of naltrexone lasts for up to 72 hours but unfortunately adherence rates have been very poor. There is a long acting, extended release, formulation of naltrexone that is released from an physical implant called the iGen/Atral-Cipan device. This extended release option has great promise in substantially extending the 'coverage' of the medication effect for the patient. The NEAT Trial is an NIHR commissioned randomised controlled trial of extended release implant versus oral standard tablet naltrexone in the NHS among 300 recently detoxified patients with heroin use disorder who are seeking relapse prevention therapy. The study will be done in three specialist clinics in London, Birmingham and Durham over three years. All participants in the trial will receive standard NHS psychological therapy over 12 weeks and will be randomised into one of three study conditions: the first group will receive an active naltrexone implant and placebo oral tablet naltrexone; the second group will receive a placebo implant and active oral tablet naltrexone; the third group will receive a placebo implant and placebo oral tablet naltrexone. Using this three group, placebo controlled design will enable us to detect the impact of each medication in addition to psychological therapy. It is expected that results will generate findings of immediate practical benefit in the NHS.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1615
Date of REC Opinion
6 Nov 2014
REC opinion
Further Information Favourable Opinion