Effectiveness of Atomoxetine treatment for methamphetamine use disorder

Phase 2

Recruiting

Conditions: 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
F15.24

Registration Number: IRCT2017070234844N1

Lead Sponsor: Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

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

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention. Timepoint: Weekly. Method of measurement: Participation in physician visit/s, psychological treatment sessions and completion of assessments.

Secondary Outcome Measures

Name	Time	Method
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).