Comparing the Atomoxetine effectiveness in retention of patients in the stimulant (Meth-Amphethamine) dependence treatment with placebo in a three month period
The main objective of this study is to compare effectiveness of atomoxetine with placebo in treatment of amphetamine-type stimulants (methamphetamine). The study is a triple-blind multi-center, phase 2, randomized controlled trial in which 90 clients with amphetamine-type stimulants use disorder will randomly assign to one of three groups including atomoxetine 120mg/d, atomoxetine 60 mg/day or placebo for three months. Inclusion criteria are having stimulant (methamphetamine) use disorder according to DSM-5, using 2 times or more methamphetamine in a week during last month and age 18 to 60 years old. The exclusion criteria are sensitivity to atomoxetine, rising of liver enzymes more than 3 times: hepatic failure, acute hepatitis, having other substance use disorders (except nicotine) and using MAOI medications during last 2 weeks. All participants will receive basic psychological interventions. Primary outcome of the study is retention in treatment and secondary outcomes of the study are methamphetamine abstinence measured by urine tests and self-report and addiction severity measured by Addiction Severity Index (ASI).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070234844N1
Registration date:2017-07-19, 1396/04/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-19, 1396/04/28
Registrant information
Name
Alireza Noroozi
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1144
Email address
noroozi_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Atomoxetine effectiveness in retention of patients in the stimulant (Meth-Amphethamine) dependence treatment with placebo in a three month period
Public title
Effectiveness of Atomoxetine treatment for methamphetamine use disorder
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research
Street address
6th Floor, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv.
City
Tehran
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.TUMS.REC. 1395.2732
Health conditions studied
1
Description of health condition studied
Other stimulants dependence syndrome
ICD-10 code
F15.24
ICD-10 code description
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
Primary outcomes
1
Description
Retention
Timepoint
Weekly
Method of measurement
Participation in physician visit/s, psychological treatment sessions and completion of assessments
Secondary outcomes
1
Description
Methamphetamine abstinence- Urine tests
Timepoint
Weekly
Method of measurement
Urine immunoassay test for methamphetamine
2
Description
Methamphetamine abstinence- Self-report
Timepoint
Weekly
Method of measurement
Self-report measured by timeline follow-back (TLFB)
3
Description
Addiction severity
Timepoint
Monthly
Method of measurement
Self-report measured by Addiction Severity Index (ASI)
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies
Full name of responsible person
Alireza Noroozi
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Psychiatric Clinic of Roozbeh Hospital
Full name of responsible person
Street address
South Kargar St, South of Lashgar Crossroad, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research
Full name of responsible person
Ms. Karimi
Street address
6th Floor, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences (TUMS), Vice-chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Dr. Alireza Noroozi
Position
Psychiatrist
Other areas of specialty/work
Street address
No 486, South Kargar St
City
Tehran
Postal code
Phone
+98 21 5542 1144
Fax
Email
noroozi_a@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Dr. Azarakhsh Mokri
Position
Assistant Professor, Psychiatric Department
Other areas of specialty/work
Street address
No 486, South Kargar St
City
Tehran
Postal code
Phone
+98 21 5542 1144
Fax
Email
mokriazr@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Alireza Noroozi
Position
Psychiatrist
Other areas of specialty/work
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
Tehran
Postal code
1336616357
Phone
+98 21 5542 1144
Fax
+98 21 5541 2232
Email
a_r_noroozi@yahoo.com
Web page address
incas.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)