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. |
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| 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] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| 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] |
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| ISSN: | 00952990 |
| DOI: | 10.1080/00952990.2021.1885677 |
