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Efficacy of automoxetine in methamphetamine dependency

Efficacy of Atomoxetine for methamphetamine users who are on methadone maintenance treatment(Randomized, double-blind, placebo-controlled clinical trials)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016041627413N1
Enrollment
82
Registered
2016-05-21
Start date
2016-01-21
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 dependence. Mental and behavioural disorders due to use of other stimulants, including caffeine

Interventions

Intervention 1: The intervention group.: Automoxetine 40 mg daily for 8 weeks. Intervention 2: the control group:placebo for 8 weeks.
Treatment - Drugs
Placebo
The intervention group.: Automoxetine 40 mg daily for 8 weeks.
the control group:placebo for 8 weeks

Sponsors

Vice chancellor for research,Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:18-65 years old? On Methadone maintenance treatment? Seeking treatment for METH use? METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV? At least weekly self-reported METH use during a preceding three month period? Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing, and not be nursing? Men must agree to use effective means of contraception during the study. Exclusion Criteria: Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician? Current opioid, alcohol or sedative physical dependence or cocaine dependence? Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, hypertension [i.e., > 160 SBP or > 100 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician? Schizophrenia or bipolar disorder of any type? present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with atomoxetine (e.g., an monoamine oxidase inhibitor (MAOI), paroxetine, fluoxetine, quinidine, dopamine, albuterol, or other ß2-agonists)? Medical contraindication to receiving atomoxetine (e.g., severe hepatic impairment, glaucoma, heart disease, hypertension, seizure disorders, documented hypersensitivity to atomoxetine); or other bronchospastic condition, (2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to atomoxetine)? Liver function tests (i.e., liver enzymes) greater than two times normal levels? Systolic blood pressure of 160 mmHg, diastolic blood pressure of 100 mmHg, or sitting heart rate of 100 beats/min or blood pressure readings > 140 systolic or > 90 diastolic on three separate, consecutive occasions? History of pheochromocytoma? Metabolic diseases such as diabetes and neurological diseases such as epilepsy? Pregnant or nursing female

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Negative urine test for methamphetamine. Timepoint: twice a week. Method of measurement: methamphetamine urine test.

Secondary

MeasureTime frame
Measure of desire for methamphetamine. Timepoint: Once every ten days. Method of measurement: by desire for drug questionnaire.;Evaluation of methamphetamine withdrawal symptoms. Timepoint: Once every ten days. Method of measurement: Methamphetamine Withdrawal Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Rabiey

kashan university of Medical Sciences

rabiey-a@kaums.ac.ir+98 31 5562 1181

Outcome results

None listed

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