Comparison the effect of Bupropion and Amantadine in reducing sexual dysfunction in patients taking methadone
Design
A randomized clinical trial without control group, with parallel groups, phase 3، without blindness that, 40 patients randomly divided into two groups of 20 subjects with block sizes of 4 and 6.
Settings and conduct
Patients who came to Shahid Zakerian addiction center in Babol and undergo methadone maintenance treatment, randomly divided into two Intervention groups with block sizes of 4 and 6. after 1 month, the International index of erectile function (IIEF) questionnaire is filled out for all patients and the score is compared with their previous score.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 20 to 70 years, Methadone Consumption, Consumers of any drugs and cigarettes or herbal medicines
Exclusion criteria:Female patients, single men, patients who are not satisfied with the study Diseases affecting sexual function (known diabetes, cardiovascular and endocrine disorders, well-known neurological disease affecting sexual function, etc.), Use any type of drug that has an effect on sexual function (e.g. Amphetamines based on patient's history).
Intervention groups
Group 1: Amantadine 100 mg (Ammorel Company) twice a day for a month
Group2: Bupropion 150 mg (Sandoz Company) at 4 PM for a month
Main outcome variables
Sexual dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170606034348N5
Registration date:2019-06-25, 1398/04/04
Registration timing:retrospective
Last update:2019-06-25, 1398/04/04
Update count:0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 121 3171
Email address
a.hamidia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Bupropion and Amantadine in reducing sexual dysfunction in patients taking methadone
Public title
Bupropion and amantadine in sexual function in patients with methadone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20 to 70 years
Consumers of any drugs and cigarettes or herbal medicines
Methadone consumption
Exclusion criteria:
Female patients
single men
patients who are not satisfied with the study
Diseases affecting sexual function (known diabetes, cardiovascular and endocrine disorders, well-known neurological disease affecting sexual function, etc.)
Use any type of drug that has an effect on sexual function (e.g. Amphetamines based on patient's history)
Age
From 20 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly divided into two groups of 20 subjects with four and six blocks and an allocation ratio of 1: 1.The participants allocation sequence in two groups performed with a Randomizer software. Opaque sealed sequentially numbered envelops used for allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
MUBABOL.HRI.REC.1396.108
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F11.281
ICD-10 code description
Opioid dependence with opioid-induced sexual dysfunction
Primary outcomes
1
Description
Sexual dysfunction
Timepoint
At the beginning of the study and one month after the start of the drug
Method of measurement
International Index of Erectile Function Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Amantadine 100 mg (Ammorel Company) twice a day for a month
Category
Treatment - Drugs
2
Description
Intervention group 2: Bupropion 150 mg (Sandoz Company) at 4 PM for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Zakirian Addiction Center
Full name of responsible person
Dr. Angela Hamidia
Street address
Baker side, Facing the tomb, Gelemahaleh intersection
City
Babol
Province
Mazandaran
Postal code
4718745811
Phone
+98 11 3232 5580
Fax
Email
a.hamidia@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.reza ghadimi
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
.
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 2033
Fax
+98 11 3219 9936
Email
a.hamidia@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad Hospital, Islamic Republic Street
City
babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 32191951
Fax
+98 11 3219 1951
Email
a.hamidia@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad Hospital, Islamic Republic Street
City
babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 32291951
Fax
+98 11 3229 1951
Email
a.hamidia@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available