Comparing of Valproate with Placebo in Reducing Methamphetamine Craving

A Comparative Study on the Effectiveness of Adding Valproate and Placebo on Reduction of the Craving in Methamphetamine-Dependent Patients during Treatment with Matrix Program

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201406027841N7

Enrollment

Registered

2014-06-06

Start date

2012-12-01

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

Methamphetamine Dependency. Mental and behavioural disorders due to use of other stimulants, including caffeine.Dependence syndrome

Interventions

Intervention 1: Intervention group: valproate tabs was started with the dose of 250 mg and within 10 days it increased to the dose of 1000 mg and this amount continued for 4 months. Intervention 2: Co

Treatment - Drugs

Placebo

Intervention group: valproate tabs was started with the dose of 250 mg and within 10 days it increased to the dose of 1000 mg and this amount continued for 4 months.

Control group: A placebo with similar medicinal form to Valproat started and continued for 4 months.

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: men and women age 18–40 years old; diagnosed with methamphetamin dependency according to DSM-IV criteria; informed acceptance to comply with study procedures. Exclusion criteria: sever medical illness that would impair the ability to participate safely in the study; a current neurological or axis I psychiatric disorders not due to substance abuse (e.g., schizophrenia, dementia) that would impair ability to participate safely in the study; current pregnancy or nursing in women; current serious suicidal intention or plan; more than 3 times elevation of AST and ALT at screening; subjects who met DSM-IV criteria for opiates dependence.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Methamphetamine Craving. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: Cocaine Craving Questionnaire-Brief (CCQ-Brief).	—

Secondary

Measure	Time frame
Drowsiness. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.;Dyspepsia. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.;Weight gain. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.;Tremor. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.	—

Measure

Time frame

Drowsiness. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.;Dyspepsia. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.;Weight gain. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.;Tremor. Timepoint: At screening and every 2 weeks up to 4 months. Method of measurement: History and Physical examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasood Ghavami

Isfahan University of Medical Sciences, Department of Psychiatry

masood.ghavami@yahoo.com+98 31 3222 2427

Outcome results

None listed

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