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The effect of adding topiramate (compared to placebo) in reducing withdrawal symptoms in opium-like substances in the substance-dependent patients

The effect of adding topiramate (compared to placebo) in reducing withdrawal symptoms in opium-like substances in the substance-dependent patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201307205280N14
Enrollment
42
Registered
2013-08-02
Start date
2012-04-03
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

opioid withdrawal symptoms. Mental and behavioural disorders due to use of opioids

Interventions

Intervention 1: Intervention group: receive topiramate ( 100 mg/day), 2 weeks. Intervention 2: Control group: receive placebo for 2 weeks.
Treatment - Drugs
Placebo
Intervention group: receive topiramate ( 100 mg/day), 2 weeks.
Control group: receive placebo for 2 weeks.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 59 Years

Inclusion criteria

Inclusion criteria: Individuals are included if they fulfil DSM-IV-TR criteria for opioid- like substance dependency. However, Patients are not included if they have opioid- like withdrawal syndrome during the recruitment period. Exclusion criteria: concomitant use of alcohol, stimulants as well as benzodiazepines; having severe medical comorbidities; patients who start to take any psychiatric medication or any significant change in dose of medication during the study and follow-up period.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of subjective withdrawal symptoms. Timepoint: At the days: 1, 3, 5, 7 and 14. Method of measurement: (OWSC) opiate withdrawal symptoms checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir Rezaei Aardani

Mashhad University of Medical Sciences

rezaeia@mums.ac.ir+98 51 1711 2540

Outcome results

None listed

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