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Evaluation of Bupropion Efficacy on Sexual Dysfunction among Male Patients on Methadone Maintenance Therapy

Protocol summary

Summary
The study was designed to investigate the efficacy of bupropion on sexual dysfunction in men receiving Methadone maintenance therapy (MMT) in addiction quitting center of Noor anad St.Aliasghar Hospital of Isfahan. During a double-blinded, placebo-controlled trial 60 male patients receiving Methadone maintenance therapy randomized to treatment(n=30) with bupropione (200 mg/day) or placebo(n=30) for 8 weeks.Male patients who received Methadone- maintained Therapy for at least 6 months, having complaints of sexual dysfunction after receiving methadone treatment, were entered the study Other inclusion criteria were: A negative history of underlying diseases such as epilepsy, diabetes, organic brain disease, and psychosis, and not receiving drugs affecting sexual function, no risk of major depressive disorder and a score of less than 16 based on the BDI-II, having a total score of 19 or more based on the Arizona Sexual Experience Scale (ASEX), no alcohol consumption . The exclusion criteria were consisted of leaving the MMT program, the decision of the therapist to stop the treatment with methadone or bupropion for any reason, and seizures. Sexual function and depression score were assessed by Arizona sexual experience scale (AXES), and Beck depression inventory II (BDI-II) self-reported questionnaires, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014032616823N1
Registration date: 2014-03-26, 1393/01/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-26, 1393/01/06
Registrant information
Name
Mehrdad Salehi
Name of organization / entity
Isfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1234 5711
Email address
me_salehi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences-Behavioral Sciences Research Center
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Bupropion Efficacy on Sexual Dysfunction among Male Patients on Methadone Maintenance Therapy
Public title
Evaluation of Bupropion Efficacy on Sexual Dysfunction among Male Patients on Methadone Maintenance Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male gender;Having the minimum level of education in reading and writing; passing at least 6 months from the Methadone maintenance Therapy( MMT); Having complaints from the cause or aggravate of sexual dysfunction after methadone treatment; Lack of underlying diseases as epilepsy, diabetes, organic brain disease, and psychosis;Not receiving drugs affecting sexual function, such as SSRI, sildenafil, testosterone, antipsychotics, cyclic antidepressants, MAO-I, the lithium, amphetamines, chlordiazepoxide, clonidine, methyldopa, spironolactone hydrochlorothiazide, barbiturates, anti-Parkinson's drugs , clofibrate, digoxin, indomethacin, propranolol and phentolamine; No risk of major depressive disorder and a score of less than 16 based on the BDI-II, Having a total score of 19 or more based on the Arizona Sexual Experience Scale (ASEX) or a score of 5 or more on one of the items of ASEX or a score of 4 or more in any of 3 items; No alcohol consumption, recent cessation of benzodiazepines, and not using drugs or stimulants. Exclusion criteria: Leaving the MMT program; the decision of the therapist to stop the treatment with methadone or bupropion for any reason, and seizures.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical commitee of Isfahan University of Medical Sciences
Street address
Hezar Jarib street
City
Isfahan
Postal code
Approval date
2009-06-09, 1388/03/19
Ethics committee reference number
388223

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire

Primary outcomes

1

Description
sexual function
Timepoint
preintervention, post intervention at the end of 2, 4, 6,and 8 weeks
Method of measurement
Arizona sexual experiences scale(ASEX)

Secondary outcomes

1

Description
Depression total score
Timepoint
preintervention, post intervention at the end of 2,4,6 and 8 weeks
Method of measurement
Beck depression scale

Intervention groups

1

Description
intervention group- bupropion tab.100 mg Po for 3 days, then twice daily( 200mg/day) for 8 weeks.
Category
Treatment - Drugs

2

Description
control group: Placebo tab.100 mg po for 3 days, then twice daily( 200mg/day) for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Addiction Quitting clinic- Noor & st.Aliaghar hospital
Full name of responsible person
Dr.Mehrdad Salehi
Street address
Ostandari street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences-Behavioral Sciences Research Center
Full name of responsible person
Dr.Mehrdad Salehi
Street address
Ostandari street- Noor & St.Aliasghar hospital Hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences-Behavioral Sciences Research Center
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
Behavioral Sciences Research Center- Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Salehi
Position
Associate professor
Other areas of specialty/work
Street address
ostandari street- Noor & st. Aliasghar Hospital
City
Isfahan
Postal code
Phone
+98 31 1222 2475
Fax
Email
me_salehi@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Behavioral Sciences Reserach Center-Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Salehi
Position
Psychiatry specialist( MD)
Other areas of specialty/work
Street address
Ostandari street- Noor & st.Aliasghar Hospital
City
Isfahan
Postal code
Phone
+98 31 1222 2475
Fax
Email
me_salehi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Isfahan (khorasgan Branch)
Full name of responsible person
Mitra Molaeinezhad
Position
PhD/ Faculty member
Other areas of specialty/work
Street address
Islamic Azad University Isfahan( khorasgan branch)
City
Isfahan
Postal code
Phone
+98 31 1535 4065
Fax
Email
melika1353@yahoo.com
Web page address
http://drmolaei.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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