OBJECTIVE: The aim of this study was to examine the benefits of amineptine, a dopamine agonist antidepressant, in treating amphetamine withdrawal. METHOD:Inpatients with amphetamine withdrawal were recruited to participate in this placebo-controlled, randomised, double-blind, parallel group, 2-week comparison of amineptine and placebo treatments. The treatment effects were evaluated by means of the self-administered Amphetamine Withdrawal Questionnaire (AWQ) and the interviewer-administered Clinical Global Impression (CGI) scale. An intention-to-treat analysis was applied to evaluate the therapeutic effects at the end of week 1 and week 2. RESULTS: Twenty-two patients took part in each treatment group. The week-1 and week-2 intention-to-treat analyses showed that the mean AWQ reversed vegetative scores (combined scores of decreased energy, increased appetite and craving for sleep items) of the amineptine group were significantly lower than those of the placebo group. The general condition of the amineptine group assessed by CGI also significantly improved at the end of week 2. Although the discontinuation rate due to dissatisfaction with treatment of amineptine group (1/21) was much lower than that of placebo group (6/22), those rates were not significantly different (p = 0.09). CONCLUSIONS:Amineptine is specifically effective for treating a major component of amphetamine withdrawal: a reversed vegetative syndrome. Although more than 2 weeks of amineptine treatment may contribute further benefits, both risks and benefits should be taken into account in doing so.
RCT Entities:
OBJECTIVE: The aim of this study was to examine the benefits of amineptine, a dopamine agonist antidepressant, in treating amphetamine withdrawal. METHOD: Inpatients with amphetamine withdrawal were recruited to participate in this placebo-controlled, randomised, double-blind, parallel group, 2-week comparison of amineptine and placebo treatments. The treatment effects were evaluated by means of the self-administered Amphetamine Withdrawal Questionnaire (AWQ) and the interviewer-administered Clinical Global Impression (CGI) scale. An intention-to-treat analysis was applied to evaluate the therapeutic effects at the end of week 1 and week 2. RESULTS: Twenty-two patients took part in each treatment group. The week-1 and week-2 intention-to-treat analyses showed that the mean AWQ reversed vegetative scores (combined scores of decreased energy, increased appetite and craving for sleep items) of the amineptine group were significantly lower than those of the placebo group. The general condition of the amineptine group assessed by CGI also significantly improved at the end of week 2. Although the discontinuation rate due to dissatisfaction with treatment of amineptine group (1/21) was much lower than that of placebo group (6/22), those rates were not significantly different (p = 0.09). CONCLUSIONS:Amineptine is specifically effective for treating a major component of amphetamine withdrawal: a reversed vegetative syndrome. Although more than 2 weeks of amineptine treatment may contribute further benefits, both risks and benefits should be taken into account in doing so.
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