@article{ezard_safety_2021,
	title = {Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study},
	volume = {11},
	copyright = {© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.},
	issn = {2044-6055, 2044-6055},
	shorttitle = {Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence},
	url = {https://bmjopen.bmj.com/content/11/5/e044696},
	doi = {10.1136/bmjopen-2020-044696},
	abstract = {Objectives To examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence.
Design A dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services.
Setting The study was conducted at two Australian stimulant use disorder treatment clinics.
Participants There were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days.
Interventions Daily, supervised LDX of 100–250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100–250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250–100 mg). Participants were followed through to week 12.
Outcomes Primary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning.
Results Fourteen of 16 participants (87.5\%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16–23) to 13 days (IQR: 11–17) over the 4-week escalation period (p=0.013).
Conclusions LDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence.
Trial registration number ACTRN12615000391572.},
	language = {en},
	number = {5},
	urldate = {2023-05-30},
	journal = {BMJ Open},
	author = {Ezard, Nadine and Clifford, Brendan and Dunlop, Adrian and Bruno, Raimondo and Carr, Andrew and Liu, Zhixin and Siefried, Krista J. and Lintzeris, Nicholas},
	month = may,
	year = {2021},
	pmid = {34006547},
	note = {Publisher: British Medical Journal Publishing Group
Section: Addiction},
	keywords = {Amphetamine, clinical pharmacology, clinical trials, substance misuse},
	pages = {e044696},
}

{"_id":"dCrFXDzaJ4nExko2J","bibbaseid":"ezard-clifford-dunlop-bruno-carr-liu-siefried-lintzeris-safetyandtolerabilityoforallisdexamfetamineinadultswithmethamphetaminedependenceaphase2doseescalationstudy-2021","author_short":["Ezard, N.","Clifford, B.","Dunlop, A.","Bruno, R.","Carr, A.","Liu, Z.","Siefried, K. J.","Lintzeris, N."],"bibdata":{"bibtype":"article","type":"article","title":"Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study","volume":"11","copyright":"© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.","issn":"2044-6055, 2044-6055","shorttitle":"Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence","url":"https://bmjopen.bmj.com/content/11/5/e044696","doi":"10.1136/bmjopen-2020-044696","abstract":"Objectives To examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence. Design A dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services. Setting The study was conducted at two Australian stimulant use disorder treatment clinics. Participants There were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days. Interventions Daily, supervised LDX of 100–250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100–250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250–100 mg). Participants were followed through to week 12. Outcomes Primary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning. Results Fourteen of 16 participants (87.5%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16–23) to 13 days (IQR: 11–17) over the 4-week escalation period (p=0.013). Conclusions LDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence. Trial registration number ACTRN12615000391572.","language":"en","number":"5","urldate":"2023-05-30","journal":"BMJ Open","author":[{"propositions":[],"lastnames":["Ezard"],"firstnames":["Nadine"],"suffixes":[]},{"propositions":[],"lastnames":["Clifford"],"firstnames":["Brendan"],"suffixes":[]},{"propositions":[],"lastnames":["Dunlop"],"firstnames":["Adrian"],"suffixes":[]},{"propositions":[],"lastnames":["Bruno"],"firstnames":["Raimondo"],"suffixes":[]},{"propositions":[],"lastnames":["Carr"],"firstnames":["Andrew"],"suffixes":[]},{"propositions":[],"lastnames":["Liu"],"firstnames":["Zhixin"],"suffixes":[]},{"propositions":[],"lastnames":["Siefried"],"firstnames":["Krista","J."],"suffixes":[]},{"propositions":[],"lastnames":["Lintzeris"],"firstnames":["Nicholas"],"suffixes":[]}],"month":"May","year":"2021","pmid":"34006547","note":"Publisher: British Medical Journal Publishing Group Section: Addiction","keywords":"Amphetamine, clinical pharmacology, clinical trials, substance misuse","pages":"e044696","bibtex":"@article{ezard_safety_2021,\n\ttitle = {Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study},\n\tvolume = {11},\n\tcopyright = {© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.},\n\tissn = {2044-6055, 2044-6055},\n\tshorttitle = {Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence},\n\turl = {https://bmjopen.bmj.com/content/11/5/e044696},\n\tdoi = {10.1136/bmjopen-2020-044696},\n\tabstract = {Objectives To examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence.\nDesign A dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services.\nSetting The study was conducted at two Australian stimulant use disorder treatment clinics.\nParticipants There were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days.\nInterventions Daily, supervised LDX of 100–250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100–250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250–100 mg). Participants were followed through to week 12.\nOutcomes Primary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning.\nResults Fourteen of 16 participants (87.5\\%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16–23) to 13 days (IQR: 11–17) over the 4-week escalation period (p=0.013).\nConclusions LDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence.\nTrial registration number ACTRN12615000391572.},\n\tlanguage = {en},\n\tnumber = {5},\n\turldate = {2023-05-30},\n\tjournal = {BMJ Open},\n\tauthor = {Ezard, Nadine and Clifford, Brendan and Dunlop, Adrian and Bruno, Raimondo and Carr, Andrew and Liu, Zhixin and Siefried, Krista J. and Lintzeris, Nicholas},\n\tmonth = may,\n\tyear = {2021},\n\tpmid = {34006547},\n\tnote = {Publisher: British Medical Journal Publishing Group\nSection: Addiction},\n\tkeywords = {Amphetamine, clinical pharmacology, clinical trials, substance misuse},\n\tpages = {e044696},\n}\n\n","author_short":["Ezard, N.","Clifford, B.","Dunlop, A.","Bruno, R.","Carr, A.","Liu, Z.","Siefried, K. J.","Lintzeris, N."],"key":"ezard_safety_2021","id":"ezard_safety_2021","bibbaseid":"ezard-clifford-dunlop-bruno-carr-liu-siefried-lintzeris-safetyandtolerabilityoforallisdexamfetamineinadultswithmethamphetaminedependenceaphase2doseescalationstudy-2021","role":"author","urls":{"Paper":"https://bmjopen.bmj.com/content/11/5/e044696"},"keyword":["Amphetamine","clinical pharmacology","clinical trials","substance misuse"],"metadata":{"authorlinks":{}},"html":""},"bibtype":"article","biburl":"https://bibbase.org/zotero/tub49573","dataSources":["zdB47AZpEkG3LzPTn"],"keywords":["amphetamine","clinical pharmacology","clinical trials","substance misuse"],"search_terms":["safety","tolerability","oral","lisdexamfetamine","adults","methamphetamine","dependence","phase","dose","escalation","study","ezard","clifford","dunlop","bruno","carr","liu","siefried","lintzeris"],"title":"Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study","year":2021}