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Divergent Effects of Opium Tincture Step-down Tapering (DST) versus Methadone Maintenance Treatment (MMT) on Sexual Function in Men with Opium Use Disorder: Evidence from a Comparative Trial

Protocol summary

Study aim
This study compared the effects of gradual stepwise treatment with opium tincture (DST) and methadone maintenance treatment (MMT) on sexual functioning in married men with opium dependence, given concerns about sexual dysfunction associated with opioid substitution therapy.
Design
A phase III, randomized, open-label, parallel-group controlled clinical trial involving 60 patients. Simple randomization was performed using a lottery method
Settings and conduct
A four-group quasi-experimental study with a pretest–posttest–follow-up design was conducted among 60 married men with opium use disorder recruited through purposive sampling at Shafa-ye Sabz Treatment Center. Participants were randomly allocated to four groups of 15 each: gradual stepwise treatment (DST), cognitive behavioral therapy (CBT), methadone maintenance treatment (MMT), and a control group. Treatment readiness, sexual functioning, and self-control were assessed at three time points: pretest, posttest, and follow-up.
Participants/Inclusion and exclusion criteria
Opium dependence, male gender, married status, no severe psychosis or cognitive impairment, no concurrent treatment, informed consent, regular attendance, and adherence to medication protocol. Premature treatment discontinuation, incomplete questionnaires at any assessment, and use of other substances during treatment.
Intervention groups
DST group (Dezhakam Step Time; gradual stepwise reduction) MMT group (Methadone Maintenance Treatment) CBT group (Cognitive Behavioral Therapy) Control group (without structured intervention)
Main outcome variables
Treatment Readiness: All three interventions (DST, CBT, and MMT) were equally effective. Sexual Functioning: DST was superior to all other groups; MMT showed worse outcomes than the control group. Self-Control: Only CBT was effective; DST showed no significant advantage.

General information

Reason for update
Acronym
DST,MMT
IRCT registration information
IRCT registration number: IRCT20261018071471N1
Registration date: 2026-10-19, 1405/07/27
Registration timing: retrospective

Last update: 2026-10-19, 1405/07/27
Update count: 0
Registration date
2026-10-19, 1405/07/27
Registrant information
Name
Ali Shaker Dolgh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3344 0094
Email address
ali.shaker2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-24, 1404/11/04
Expected recruitment end date
2026-06-25, 1405/04/04
Actual recruitment start date
2026-01-25, 1404/11/05
Actual recruitment end date
2026-06-28, 1405/04/07
Trial completion date
2026-06-29, 1405/04/08
Scientific title
Divergent Effects of Opium Tincture Step-down Tapering (DST) versus Methadone Maintenance Treatment (MMT) on Sexual Function in Men with Opium Use Disorder: Evidence from a Comparative Trial
Public title
The Effects of Opium Tincture Administered Through a Stepwise Gradual Reduction Method and Methadone on Sexual Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Opium dependence diagnosed through a clinical interview in accordance with the DSM-5-TR criteria male gender being married absence of severe psychotic disorders or cognitive impairment no history of simultaneous participation in other similar treatment programs provision of informed consent and commitment to regular attendance o use of pharmaceutical medications outside the assigned treatment protocol
Exclusion criteria:
Severe psychotic disorders or cognitive impairment a history of concurrent participation in other similar treatment programs use of pharmaceutical medications outside the assigned treatment protocol
Age
From 20 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple randomization. Four study groups were formed, and the four study conditions, including gradual stepwise treatment (DST), cognitive behavioral therapy (CBT), methadone maintenance treatment (MMT), and the control condition, were subsequently assigned to the groups by lottery. Randomization Unit: Study group. Randomization Tool: Lottery using paper slips bearing the names of the treatment conditions and the control condition. Random Sequence Generation: After the four participant groups had been formed, the names of the four study conditions, namely gradual stepwise treatment, cognitive behavioral therapy, methadone maintenance treatment, and the control condition, were written on separate paper slips. Each condition was then assigned to one of the four groups through a lottery-based procedure. Allocation Concealment: In this study, the treatment conditions were allocated to the groups through a lottery-based procedure. No separate procedure for allocation concealment was implemented apart from the lottery process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Respected Ethics Committee of the Islamic Azad University, Urmia Branch
Street address
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۶۹-۶۳۸۹۶
Approval date
2026-04-21, 1405/02/01
Ethics committee reference number
IR.IAU.URMIA.REC.1405.013

Health conditions studied

1

Description of health condition studied
opioid sexual dysfunction
ICD-10 code
F11.181
ICD-10 code description
Opioid abuse with opioid-induced sexual dysfunction

Primary outcomes

1

Description
Total score on the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), comprising 19 items and three subscales: Recognition, Ambivalence, and Taking Steps. Responses are rated on a five-point Likert scale. Higher scores indicate greater readiness to change addictive behaviors.
Timepoint
Three assessments: baseline (before the intervention), post-test (immediately after completion of the three-month treatment period), and follow-up (at a specified interval after treatment completion)
Method of measurement
Self-report questionnaire completed by the participant in the presence of the researcher/therapist.

2

Description
Total score on the International Index of Erectile Function (IIEF), comprising 15 self-report items across five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Total scores range from 0 to 75, with higher scores indicating better sexual functioning.
Timepoint
Three assessments: baseline (before the intervention), post-test (immediately after completion of the three-month treatment period), and follow-up (at a specified interval after treatment completion)
Method of measurement
Self-report questionnaire completed by the participant in the presence of the researcher/therapist.

3

Description
Total score on the Brief Self-Control Scale (BSCS), comprising 13 self-report items. Total scores range from 13 to 65, with higher scores indicating greater self-control/behavioral self-regulation.
Timepoint
Three assessments: baseline (before the intervention), post-test (immediately after completion of the three-month treatment period), and follow-up (at a specified interval after treatment completion).
Method of measurement
Self-report questionnaire completed by the participant in the presence of the researcher/therapist.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Gradual Stepwise Reduction
Category
Treatment - Drugs

2

Description
Intervention group: Methadone Maintenance Treatment (MMT)
Category
Treatment - Drugs

3

Description
Intervention group: Cognitive Behavioral Therapy (CBT)
Category
Treatment - Drugs

4

Description
Control group: control
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa-ye Sabz Addiction Treatment Clinic
Full name of responsible person
Ms. Barkhordari
Street address
No. 948, 3rd Floor, Unit 12, Resalat Street, Farjam Street, Ayat Intersection, Sadaf Square.
City
Tehran
Province
Tehran
Postal code
1646657566
Phone
+98 21 7724 4546
Email
l.shabani.156@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
dr.Ali.Shaker Dolgh
Street address
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۶۹-۶۳۸۹۶
Phone
+98 44 3344 0094
Email
l.shabani.156@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
I had no source of funding.
Proportion provided by this source
1
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Ali.Shaker
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۶۹-۶۳۸۹۶
Phone
+98 44 3344 0094
Email
Ali.shaker2000@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Skaker Dolgh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۶۹۶۳۸۹۶
Phone
+98 44 3344 0094
Email
Ali.shaker2000@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Shaker Dolgh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology, School of Humanities, Urmia Branch, Islamic Azad University, Urmia, West Azerbaijan Province, Iran
City
Urmia
Province
West Azarbaijan
Postal code
۵۷۱۶۹۶۳۸۹۶
Phone
+98 44 3344 0094
Email
Ali.shaker2000@gmail.com

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The data are recorded in written form on paper.
When the data will become available and for how long
Access will begin six months after publication.
To whom data/document is available
Researchers employed at academic and scientific institutions.
Under which criteria data/document could be used
There are no other specific conditions
From where data/document is obtainable
l.shabani.156@gmail.com
What processes are involved for a request to access data/document
Please contact us only via email.
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