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Authors
Morley, Kirsten C. https://orcid.org/0000-0002-0868-9928
Kranzler, Henry R.
Luquin, Natasha
Baillie, Andrew
Shanahan, Marian
Trent, Ronald
Teesson, Maree
Haber, Paul S.
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Funding
Funding for this research was provided by:
National Health and Medical Research Council (APP1104288)
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Article History
Received: 4 May 2018
Accepted: 27 July 2018
First Online: 16 August 2018
Ethics approval and consent to participate
: Ethics approval for the study has been granted by the Sydney Local Health District Ethics Review Committee (X16–0231 and HREC/16/RPAH/283). Participants are provided with an approved plain language information sheet and provide written consent to participate. The protocol is version 8 (X16–0231, 16 February 2018). The study involves off-label use of a registered medication in Australia. Approval for this trial has been given under the Clinical Trial Notification scheme of the Therapeutics Goods Administration (2013/0060). The trial is sponsored by Sydney Local Health District and was registered with the National Institutes of Health clinical trials registry retrospectively on 27 March 2018 (NCT03479086; ). Participants are advised of their right to seek compensation from the study sponsor in the event of harm arising from trial participation. Protocol amendments to the clinical protocol will be updated at the clinical trials registry following approval by the corresponding ethics review committee.
: There are no restrictions on publication from the sponsor or other parties. Publications will be authored by the investigators and authorship offered according to NHMRC criteria.
: Dr Kranzler has been a consultant, advisory board member or continuing medical education speaker for Alkermes, Lundbeck and Otsuka. He is a member of the American Society of Clinical Psychopharmacology’s Alcohol Clinical Trials Initiative (ACTIVE), which in the last 3 years was supported by AbbVie, Alkermes, Amygdala Neurosciences, Arbor, Ethypharm, Indivior, Lilly, Lundbeck, Otsuka and Pfizer. Dr Kranzler is named as an inventor on PCT patent application 15/878,640 entitled: “Genotype-guided dosing of opioid agonists,” which was filed on 24 January 2018.The authors declare that they have no competing interests.
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