Substance dependency. Mental and behavioural disorders due to psychoactive substance use
Conditions
Interventions
Intervention 1: Pexacerfont prescription that is a strong selective CRF1 antagonist and passes BBB .this drug has good bioavailability.it's metabolism is hepatic which has renal and gastrointestinal e
Treatment - Drugs
Placebo
Pexacerfont prescription that is a strong selective CRF1 antagonist and passes BBB .this drug has good bioavailability.it's metabolism is hepatic which has renal and gastrointestinal excreation . it's
Placebo prescription that it's apparent form is perfectly similar to drug.
Sponsors
Tehran University of Medical Sciences
state Welfare Organization of Iran
Eligibility
Sex/Gender
All
Age
20 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Nonattendance currently in another clinical study. 2) Meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for methamphetamine.3) both male and female (if female and of child bearing potential, agree to use an acceptable method of birth control during the study).4) Age: 20-55 years old. Exclusion criteria: 1) Important psychiatric disease for example Major Depression, Schizophrenia, Bipolar disease. 2) Use of corticosteroids since 6 month ago (local or inhaler use is not important). 3) Use of drugs that effect on CY3A4 enzyme for example Carbamazepine and Erythromycine. 4) Diabetes type 1 and 2. 5) Convulsion since 3 month ago. 6) Important neurologic disease including Parkinson, MS, Strock, CP. 7) Pregnancy. 8) Laboratory results as below: QTC >475 msec; Hb2.5 times upper limit of normal; SGPT (ALT) > 2.5 times upper limit of normal; bilirubin 2 times upper limit of normal total; BUN and CR >upper limit of normal; systolic BP> 150 mmHg or diastolic BP > 100mmHg; positive HBS Ag or HCV Ab tests; positive HIV Ab test.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metamphetamine, canabis, opium and methadone. Timepoint: Before begining the drug or placebo and follow weekly. Method of measurement: Urine test.;Craving. Timepoint: Before begining the drug or placebo and follow weekly. Method of measurement: Visual Analog Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety. Timepoint: Biweekly that begin in second day of trial and continue biweekly until end of trial. Method of measurement: Hamilton Anxiety questionare.;Depression. Timepoint: Biweekly that begin in second day of trial and continue biweekly until end of trial. Method of measurement: Hamilton Depresion questionare. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Shahin Akhondzadeh
Tehran University of Medical Sciences
Outcome results
None listed