Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial

Elsevier

Available online 7 November 2022, 109692

Drug and Alcohol DependenceHighlights•

There is no approved pharmacotherapy option for methamphetamine withdrawal

This is the first clinical trial of lisdexamfetamine for methamphetamine withdrawal

Lisdexamfetamine is safe and feasible for treating acute withdrawal

Participants found this treatment highly acceptable

More work is needed to determine the efficacy of this treatment

ABSTRACTBackground

There is no effective treatment for methamphetamine withdrawal. This study aimed to determine the feasibility and safety of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine (MA) withdrawal.

Methods

Open-label, single-arm pilot study, in an inpatient drug and alcohol withdrawal unit assessing a tapering dose of oral lisdexamfetamine dimesylate commencing at 250 mg once daily, reducing by 50 mg per day to 50 mg on Day 5. Measures were assessed daily (days 0-7) with 21-day telephone follow-up. Feasibility was measured by the time taken to enroll the sample. Safety was the number of adverse events (AEs) by system organ class. Retention was the proportion to complete treatment. Other measures included the Treatment Satisfaction Questionnaire for Medication (TSQM), the Amphetamine Withdrawal Questionnaire and craving (Visual Analogue Scale).

Results

Ten adults seeking inpatient treatment for MA withdrawal (9 male, median age 37.1 years [IQR 31.7 to 41.9]), diagnosed with MA use disorder were recruited. The trial was open for 126 days; enrolling one participant every 12.6 days. Eight of ten participants completed treatment (Day 5). Two participants left treatment early. There were no treatment-related serious adverse events (SAEs). Forty-seven AEs were recorded, 17 (36%) of which were potentially causally related, all graded as mild severity. Acceptability of the study drug by TSQM was rated at 100% at treatment completion. Withdrawal severity and craving reduced through the admission.

Conclusion

A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting.

Keywords

methamphetamine

lisdexamfetamine

Withdrawal

safety

Clinical trial

Pharmacotherapy

treatment

stimulant

View full text

© 2022 Published by Elsevier B.V.

留言 (0)

沒有登入
gif