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Effect of amantadine on methamphetamine-withdrawal induced fatigue

Not Applicable
Conditions
Fatigue.
Malaise and fatigue
Registration Number
IRCT2015111524853N2
Lead Sponsor
Deputy of research and technology developement, Ahvaz Jundishapur University of Medical Sciences
Brief Summary

Background and aims: Methamphetamine (MA) is the second most popular illicit drug worldwide causing major challenges to public health. Abrupt cessation of regular MA use induces several withdrawal symptoms, among which is persistent fatigue that mayremain for few weeks after abstinence. Fatigue can disrupt the individual’s social and professional lives, especially in youth population, as well as increasing the risk of relapse. The aim of this study is to assess the effects of amantadine on the treatment of persistent fatigue in MA-abstained individuals.<br /> Methods: The study is a prospective, double-blind, randomized, placebo-controlled trial and was conducted in the outpatient addiction clinic of Imam Khomeini Hospital in Ahvaz, Iran. 36 MA-abstained individuals who sought treatment for persistent fatigue were enrolled in the trial and randomly assigned to two groups receiving either amantadine 100 mg/day or placebo for a duration of one month. Treatment response was evaluated using two scales including Fatigue Severity Scale (FSS) and Chalder Fatigue Scale (CFS), recorded at the beginning and end of trial.<br /> Findings: A substantial reduction in both fatigue scales was found in the amantadine group, while there was no significant change in the placebo group (P

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
36
Inclusion Criteria

subjects who experience fatigue post methamphetamine cessation (diagnosis made by DSMIV-TR criteria); no other disorders like diabetes, hypertention and hyper or hypo thyroidism; no use of alcohol or drugs; taking another drug that has interaction with amantadine ;age between 18 and 40.
exclusion criteria: patients who don't sign the consent form; patients that don't have a good drug compliance in the process of the trial; developement of any side effect or condition that needs discontinuation of amantadine

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fatigue. Timepoint: prior to intervention and 1 month after intervention. Method of measurement: FSS score from the test.
Secondary Outcome Measures
NameTimeMethod
Adveres drug reaction. Timepoint: 1 month. Method of measurement: patient report.
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