The effectiveness of topiramate in reducing methamphetamine craving

Phase 2

Recruiting

• Conditions: Metamphetamine use disorder.; Other stimulant dependence, uncomplicated; F15.20

• Registration Number: IRCT20180929041167N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Age between 18 to 65 years
Current diagnosis of methamphetamine use disorder based on DSM-V criteria
Positive urine test for methamphetamine prior to study entry or self report of methamphetamine use for at least 5 days during the previous month
Body mass index equal or greater than 18

Exclusion Criteria

Comorbid medical conditions based on medical history, physical examination, and laboratory test results
Use of other substances (except for methadone as a maintenance therapy, nicotine, and cannabis) confirmed by toxicology screening
Use of medications known to interact with topiramate such as acetazolamide, ergotamines, simvastatin, lovastatin, and antiepileptics
History of hypersensetivity to topiramate
Impaired renal function
History of kidney stone
Serious mood disorders (i.e. major depressive disorder, bipolar disorder), suicidal ideation, schizophrenia, psychosis (exept for transient psychosis due to substance use), dementia, psychiatric disorders requiring psychotropic medications (exept for medication for insomnia)
Use of medications with potential effect on methamphetamine craving (i.e. modafinil, bupropion, naltrexone, N-acetylcycteine)
Pregnancy and or lactation
Currently (during a month prior to the study) in treatment for methamphetamine use
Having DSM-V diagnosis of any other substance use disorders in the previous year
Coronary vascular disease confirmed by physical examination and electrocardiography
History of seizure
History of glucoma
Having DSM-V axis I psychiatric disorders that will probabely need treatment during the study duration or that are unstable
Patients referred by court seeking treatment for penatly rebate

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metamphemine craving. Timepoint: Before intervention, at the end of each month after intervention until 6 months (0-1-2-3-4-5-6). Method of measurement: Stimulant craving questionnaire.;Positive urine toxicology test for methamphetamine. Timepoint: Before intervention, at the end of each month after intervention until 6 months (0-1-2-3-4-5-6). Method of measurement: Urine toxicology test.;Addiction severity index composite score. Timepoint: Before intervention, at the end of each 3 months after intervention until 6 months (0-3-6). Method of measurement: Addiction severity index-composite.

Secondary Outcome Measures

Name	Time	Method
Drug Side Effects. Timepoint: Before intervention and at the end of each month after intervention until 6 months (0-1-2-3-4-5-6). Method of measurement: Drug side effects questionnaire.