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Open‐label pilot study of lisdexamfetamine for cocaine use disorder.

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Title: Open‐label pilot study of lisdexamfetamine for cocaine use disorder.
Authors: Mariani, John J. (AUTHOR), Choi, C. Jean (AUTHOR), Pavlicova, Martina (AUTHOR), Mahony, Amy L. (AUTHOR), Brooks, Daniel J. (AUTHOR), Grabowski, John (AUTHOR), Levin, Frances R. (AUTHOR)
Source: American Journal of Drug & Alcohol Abuse. 2021, Vol. 47 Issue 3, p402-409. 8p.
Subjects: United States. Food & Drug Administration, Cocaine-induced disorders, Drug side effects, Drug dosage, Pilot projects, Adults
Abstract: Background: Cocaine use disorder (CUD) is a substantial public health problem with no FDA-approved medication treatments. Psychostimulants have shown promise as pharmacotherapy for CUD. Lisdexamfetamine, a novel prodrug psychostimulant, is roughly 40–50% as potent as dextroamphetamine. Objectives: To evaluate the safety, tolerability, and optimal dosing of lisdexamfetamine for treating CUD. Methods: Open-label, 8-week trial of 17 CUD adults. Participants were titrated to the maximum tolerated dose of 140 mg over 2-week period and maintained for 4 weeks, followed by a two-week taper period. The primary outcome measures were the maximum daily dose achieved during the study period and tolerability as measured by medication-related study drop-out. Results: Among the 16 participants with post-enrollment data, the mean dose of lisdexamfetamine achieved was 118.1 mg (standard deviation (SD) = 40.4), mean retention was 6.5 weeks (SD = 2.0), and no participants discontinued study medication due to adverse effects. Four participants had dose reductions due to adverse effects and continued in the trial. Six participants (37.5%) were abstinent for the last 3 weeks of their study participation. Mean dollars of cocaine spent per day significantly decreased from $19.72 at baseline to $7.57 during the last 3 weeks of study participation (t15 = 3.60, p =.003). The mean percent of using days significantly decreased from 25% at baseline to 12% during the last 3 weeks of study participation (t15 = 3.33, p =.005). Conclusion: The use of lisdexamfetamine for CUD in doses ranging to 140 mg daily was safe and generally well tolerated. [ABSTRACT FROM AUTHOR]
Copyright of American Journal of Drug & Alcohol Abuse is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Label: Title
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  Data: Open‐label pilot study of lisdexamfetamine for cocaine use disorder.
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  Data: <searchLink fieldCode="AR" term="%22Mariani%2C+John+J%2E%22">Mariani, John J.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Choi%2C+C%2E+Jean%22">Choi, C. Jean</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pavlicova%2C+Martina%22">Pavlicova, Martina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mahony%2C+Amy+L%2E%22">Mahony, Amy L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brooks%2C+Daniel+J%2E%22">Brooks, Daniel J.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Grabowski%2C+John%22">Grabowski, John</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Levin%2C+Frances+R%2E%22">Levin, Frances R.</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22American+Journal+of+Drug+%26+Alcohol+Abuse%22">American Journal of Drug & Alcohol Abuse</searchLink>. 2021, Vol. 47 Issue 3, p402-409. 8p.
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  Data: <searchLink fieldCode="DE" term="%22United+States%2E+Food+%26+Drug+Administration%22">United States. Food & Drug Administration</searchLink><br /><searchLink fieldCode="DE" term="%22Cocaine-induced+disorders%22">Cocaine-induced disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+side+effects%22">Drug side effects</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+dosage%22">Drug dosage</searchLink><br /><searchLink fieldCode="DE" term="%22Pilot+projects%22">Pilot projects</searchLink><br /><searchLink fieldCode="DE" term="%22Adults%22">Adults</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: Cocaine use disorder (CUD) is a substantial public health problem with no FDA-approved medication treatments. Psychostimulants have shown promise as pharmacotherapy for CUD. Lisdexamfetamine, a novel prodrug psychostimulant, is roughly 40–50% as potent as dextroamphetamine. Objectives: To evaluate the safety, tolerability, and optimal dosing of lisdexamfetamine for treating CUD. Methods: Open-label, 8-week trial of 17 CUD adults. Participants were titrated to the maximum tolerated dose of 140 mg over 2-week period and maintained for 4 weeks, followed by a two-week taper period. The primary outcome measures were the maximum daily dose achieved during the study period and tolerability as measured by medication-related study drop-out. Results: Among the 16 participants with post-enrollment data, the mean dose of lisdexamfetamine achieved was 118.1 mg (standard deviation (SD) = 40.4), mean retention was 6.5 weeks (SD = 2.0), and no participants discontinued study medication due to adverse effects. Four participants had dose reductions due to adverse effects and continued in the trial. Six participants (37.5%) were abstinent for the last 3 weeks of their study participation. Mean dollars of cocaine spent per day significantly decreased from $19.72 at baseline to $7.57 during the last 3 weeks of study participation (t15 = 3.60, p =.003). The mean percent of using days significantly decreased from 25% at baseline to 12% during the last 3 weeks of study participation (t15 = 3.33, p =.005). Conclusion: The use of lisdexamfetamine for CUD in doses ranging to 140 mg daily was safe and generally well tolerated. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
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  Data: <i>Copyright of American Journal of Drug & Alcohol Abuse is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1080/00952990.2021.1885677
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        Text: English
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      – SubjectFull: Cocaine-induced disorders
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      – TitleFull: Open‐label pilot study of lisdexamfetamine for cocaine use disorder.
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              Text: 2021
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