Skip to content

The effectiveness of topiramate in reducing methamphetamine craving

Randomized clinical trial of the comparison of the effectiveness of topiramate in reducing craving in patients with methamphetamine use disorder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180929041167N1
Enrollment
56
Registered
2022-09-19
Start date
2019-07-22
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metamphetamine use disorder. Other stimulant dependence, uncomplicated

Interventions

Intervention 1: Intervention group: Half of the participants will be treated by topiramate (Aryia pharmaceutical company). The medication will start at the dose of 25 mg once per day orally and gradua

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamidreza Ahmadkhaniha

Iran University of Medical Sciences

dr_ahmadkhaniha@yahoo.com+98 21 4452 5615

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026