Other stimulants dependence syndrome. Dependence syndrome: A cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite
Conditions
Interventions
Intervention 1: Atomoxetine 120 mg group: Treatment will start with 40 mg/day atomoxetine capsule manufactured by Tadbir Kalay-e Jam Pharmaceutical Company for first week (days 1-7) and will continue
Treatment - Drugs
Atomoxetine 120 mg group: Treatment will start with 40 mg/day atomoxetine capsule manufactured by Tadbir Kalay-e Jam Pharmaceutical Company for first week (days 1-7) and will continue with 80 mg/day a
Atomoxetine 60 mg group: Treatment will start with 20 mg/day atomoxetine capsule manufactured by Tadbir Kalay-e Jam Pharmaceutical Company for first week (days 1-7) and will continue with 40 mg/day at
Placebo group: Patients will receive placebo capsules which are exactly similar to capsules of other study arms and will be manufactured by Tadbir Kalay-e Jam Pharmaceutical Company. Placebo capsules
Sponsors
Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1- Diagnosis of methamphetamine use disorder based on DSM-5; 2- Using methamphetamine 2 times or more in week during last month; 3- Age: 18 to 60 years old; 4. Referring to Psychiatric Clinic of Roozbeh Hospital or Iranian National Center for Addiction Studies (INCAS) Clinic Exclusion criteria: 1. Sensitivity to Atomoxetine; 2. Rising liver enzymes more than three times; Hepatic failure, acute hepatitis; 3. Other substance use disorders including alcohol, opioids and sedative and hypnotic medications (except nicotine); 4. More than 2 times illicit opioid use during last month; 5. Use of mono-amine oxidase inhibitor (MAOI) medications during last 2 weeks; 6. Severe cardiac disorder, history of MI during last month, uncontrolled hypertension (HTN); 7.Pregnancy or breastfeeding; 8. Risk of suicide, homicide or violence; 9. Psychosis; 10. Unable to comprehend study protocol and answer questionnaires; 11. Receiving opioid agonist medications such as MMT.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention. Timepoint: Weekly. Method of measurement: Participation in physician visit/s, psychological treatment sessions and completion of assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Methamphetamine abstinence- Urine tests. Timepoint: Weekly. Method of measurement: Urine immunoassay test for methamphetamine.;Methamphetamine abstinence- Self-report. Timepoint: Weekly. Method of measurement: Self-report measured by timeline follow-back (TLFB).;Addiction severity. Timepoint: Monthly. Method of measurement: Self-report measured by Addiction Severity Index (ASI). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Alireza Noroozi
Iranian National Center for Addiction Studies (INCAS)
Outcome results
None listed