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A comparative study of the effectiveness of cognitive behavioral interventions and sildenafil on sexual function in methadone patients

Protocol summary

Study aim
1) Determining and comparing the mean score of sexual function before and one month after the intervention in the two groups 2) Determining and comparing the mean score of quality of sexual life before and one month after the intervention in the two groups 3) Determining and comparing the mean score of sexual self-efficacy before and one month after the intervention in the two groups
Design
A two-group, single-blind, randomized, phase-3, parallel clinical trial on 70 methadone-treated patients. Excel software (rand function) will be used for randomization.
Settings and conduct
People with drug abuse who have been on methadone treatment for at least three months will be selected by convenience method. These people are selected from Navid Salamat Addiction Treatment Center located in Motahhari St., Isfahan. A trained physician and sex therapist psychologist will explain the purpose of the study to patients treated with methadone in a private environment and taking into account the patient's comfort individually
Participants/Inclusion and exclusion criteria
Methadone treatment for at least three months, not receiving psychotherapy and medication before Entry into research, willingness to participate in research, age over 18 years, literacy, not having acute mental disorders such as psychosis, bipolar disorder, physically approved schizophrenia, being married and having sex with a regular sexual partner for at least 3 years Month, erection performance questionnaire score less than 21
Intervention groups
Sildenafil tablets (25 mg) will be given daily for one month in the intervention group. In the psychological intervention group, the cognitive-behavioral approach will be held by a trained physician in 4 sessions of 90 minutes per week for 4 weeks.
Main outcome variables
Male sexual function; The quality of men's sexual life; Sexual self-efficacy - erectile dysfunction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191224045887N1
Registration date: 2021-08-28, 1400/06/06
Registration timing: prospective

Last update: 2021-08-28, 1400/06/06
Update count: 0
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
zahra amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3657
Email address
z.amini@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of cognitive behavioral interventions and sildenafil on sexual function in methadone patients
Public title
Comparison of the effect of sildenafil and education on sexual activity of methadone users
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Methadone treatment for at least three months Willingness to participate in research Age over 18 years ability to read and write Married and having sex with a regular sexual partner for at least 3 months Erection performance index questionnaire score less than 21
Exclusion criteria:
Receive psychotherapy and medication within three months before entering the study Acute mental disorder such as psychosis, bipolar disorder, schizophrenia approved by a doctor Having hypertension Patients with anatomical problems in the penis and other sexual disorders
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
A list of eligible people will be created for randomization. Then people will be individually divided into two groups using Excel software. Group 1, drug group and group 2 will be educational intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
People in the intervention group of sildenafil tablets (25 mg) will be prescribed daily for one month. In the psychological intervention group, the cognitive-behavioral approach will be held by a trained physician in 4 sessions of 90 minutes per week for 4 weeks.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Headquarters of the Ministry of Health, Treatment and Medical Education, Ghods Town (West), between South Flamek and Zarafshan, Tehran, Iran
City
Isfahan
Province
Isfehan
Postal code
8167933461
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.MUI.MED.REC.1400.404

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 function score in the Male Sexual health Questionnaire
Timepoint
Before the intervention and 30 days after the intervention
Method of measurement
Men's Sexual Health Questionnaire

2

Description
Men's sexual quality of life score from the sexual quality of life questionnaire
Timepoint
Before the intervention and 30 days after the intervention
Method of measurement
Sexual Quality of Life questionnaire

3

Description
Score of sexual self-efficacy scale - erectile dysfunction
Timepoint
Before the intervention and 30 days after the intervention
Method of measurement
Sexual Self Efficacy Scale-Erectile Functioning (SSES-E)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Sildenafil tablets (25 mg) once daily for one month from Marham Daroo Company
Category
Rehabilitation

2

Description
Second intervention group: Psychological intervention group with a cognitive-behavioral approach will be held by a trained physician in 4 sessions of 90 minutes per week for 4 weeks.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Navid Salamat Addiction Treatment Center
Full name of responsible person
Mostafa Rezaie
Street address
first floor, Motahhari Boulevard, Imam Khomeini Square, North Vesal Street, Parmis Complex,
City
Isfahan
Province
Isfehan
Postal code
8167933461
Phone
+98 31 5264 4700
Email
z.amini@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Third floor, building number 4, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8167933461
Phone
+98 31 3792 8126
Email
zahraamini63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 1, South Masroor St., Third َAbshar St.
City
Isfahan
Province
Isfehan
Postal code
8167933461
Phone
+98 31 3792 8126
Email
z.amini@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8167933461
Phone
+98 31 3669 3657
Fax
Email
z.amini@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 1, South Masroor St., Third َAbshar St.
City
Isfahan
Province
Isfehan
Postal code
8167933461
Phone
+98 31 3792 8126
Email
z.amini@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be published after deleting the identification details
When the data will become available and for how long
Access starts three months after the results are published
To whom data/document is available
All people will be able to access it with an official letter from a reputable center
Under which criteria data/document could be used
If data is needed for meta-analysis, the data will be provided to the applicant
From where data/document is obtainable
By email to Dr. Zahra Amini at z.amini@med.mui.ac.ir
What processes are involved for a request to access data/document
The applicant must receive the data by an official letter from the Vice Chancellor for Research of Isfahan University of Medical Sciences
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