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Comparing of Buprenorphine with Placebo in Reducing Methamphetamine Craving

Comparing the Efficacy of Adding Buprenorphine with Placebo in Reducing Craving in Methamphetamine Dependent Patients during Treatment with Matrix Model

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201406017841N6
Enrollment
40
Registered
2014-06-06
Start date
2012-01-01
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: Buprenorphine sublingual tab began at a dose of 2 mg per day and increased to 6 mg within 7 days (3 sublingual tablets) and this amount continued for 4 months. Inte
Treatment - Drugs
Placebo
Intervention group: Buprenorphine sublingual tab began at a dose of 2 mg per day and increased to 6 mg within 7 days (3 sublingual tablets) and this amount continued for 4 months.
Control group: A placebo with similar medicinal form to buprenorphine which is in sublingual form, began and continued for 4 months.

Sponsors

Isfahan University of Medical Sciences, Behavioral Sciences Research Center
Lead Sponsor

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

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

Secondary

MeasureTime frame
Vomiting. 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.;Drowsiness. 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 ContactAli Reza Emadossadati

Isfahan University of Medical Sciences, Department of Psychiatry

ali.emad47@gmail.com+98 31 3222 2427

Outcome results

None listed

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