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IRCT2017070234844N1 IRCT 2017-07-19 Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research Effectiveness of Atomoxetine treatment for methamphetamine use disorder Comparing the Atomoxetine effectiveness in retention of patients in the stimulant (Meth-Amphethamine) dependence treatment with placebo in a three month period 2017-08-23 anticipated 90 Complete https://irct.ir/trial/26517 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Other stimulants dependence syndrome. 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 with 80 mg/day atomoxetine in second week (days 8-14). The dose will be increased to final dose of 120 mg/day from week 3 (day 15) of treatment. In case of adverse events or intolerance of medication, the rate of dose increase will be decreased. The capsules of this group will be exactly similar to the capsules of other groups. Medication will prescribed orally, once a day at morning. All patients will receive twice weekly individual basic cognitive, behavioral counselling during the study and after it. Intervention 2: 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 atomoxetine in second week (days 8-14). The dose will be increased to final dose of 60 mg/day from week 3 (day 15) of treatment. The capsules of this group will be exactly similar to the capsules of other groups. Medication will prescribed orally, once a day at morning. All patients will receive twice weekly individual basic cognitive, behavioral counselling during the study and after it. Intervention 3: 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 will include starch. All patients will receive one capsule in first week, 2 capsules in second week and 3 capsules for the rest of study once a day at morning. The patients will receive medication for 12 weeks. After that if they want they could receive medication on open-label basis. All patients will receive twice weekly individual basic cognitive, behavioral treatment during the study and after it.
public Dr. Alireza Noroozi
No 486, South Kargar St
Tehran Iran (Islamic Republic of) +98 21 5542 1144 noroozi_a@razi.tums.ac.ir Iranian National Center for Addiction Studies (INCAS) scientific Dr. Azarakhsh Mokri
No 486, South Kargar St
Tehran Iran (Islamic Republic of) +98 21 5542 1144 mokriazr@sina.tums.ac.ir Iranian National Center for Addiction Studies (INCAS) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 60 years Both F15.24 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 Treatment - Drugs Treatment - Drugs 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 atomoxetine in second week (days 8-14). The dose will be increased to final dose of 120 mg/day from week 3 (day 15) of treatment. In case of adverse events or intolerance of medication, the rate of dose increase will be decreased. The capsules of this group will be exactly similar to the capsules of other groups. Medication will prescribed orally, once a day at morning. All patients will receive twice weekly individual basic cognitive, behavioral counselling during the study and after it. 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 atomoxetine in second week (days 8-14). The dose will be increased to final dose of 60 mg/day from week 3 (day 15) of treatment. The capsules of this group will be exactly similar to the capsules of other groups. Medication will prescribed orally, once a day at morning. All patients will receive twice weekly individual basic cognitive, behavioral counselling during the study and after it. 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 will include starch. All patients will receive one capsule in first week, 2 capsules in second week and 3 capsules for the rest of study once a day at morning. The patients will receive medication for 12 weeks. After that if they want they could receive medication on open-label basis. All patients will receive twice weekly individual basic cognitive, behavioral treatment during the study and after it. Retention. Timepoint: Weekly. Method of measurement: Participation in physician visit/s, psychological treatment sessions and completion of assessments. 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). Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research Approved 2016-06-21 Ethic Committee of Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research 6th Floor, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv. Tehran Iran (Islamic Republic of)