Investigation of the additive effect of De-Addicta product in treatment of opioid use disorder

Investigating the additive effects of De-addicta to methadone on treatment retention and craving in patients with opioid use disorder under methadone maintenance treatment referring to opioid agonist treatment outpatient clinics; 3 months intervention (first phase)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230826059263N1

Enrollment

100

Registered

2023-08-30

Start date

2024-11-10

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid use disorder. Opioid dependence

Interventions

Intervention 1: Intervention group: In the intervention group, D-Addicta capsules are prescribed for the patients who are currently receiving methadone treatment. This capsule will start with a dose o

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Men or women among 18 to 65 years old With opioid use disorder according to DSM V criteria Positive urine test for opioid use disorder

Exclusion criteria

Exclusion criteria: Alcohol dependency Dependency to other drugs except opioids like stimulants (positive urine test for stimulants) With sever psychiatric disorders except substance use disorder according to DSM V (including psychotic disorder and suicide risk) Current use of psychiatric medications Breastfeeding and pregnant women Blood pressure higher than 140/90 mm Hg With sever medical diseases (including glaucoma, urinary retention, epilepsy, Parkinson) anti social personality inability in answering the questions

Design outcomes

Primary

Measure	Time frame
Craving score in Obsessive Compulsive Drug Use Scale. Timepoint: Before treatment, After treatment, 3 months after treatment. Method of measurement: Obsessive Compulsive Drug Use Scale.;The number of days patients participate in treatment. Timepoint: Before treatment, After treatment, 3 months after treatment. Method of measurement: Counting the number of days of patients' participation in treatment.	—

Measure

Time frame

Craving score in Obsessive Compulsive Drug Use Scale. Timepoint: Before treatment, After treatment, 3 months after treatment. Method of measurement: Obsessive Compulsive Drug Use Scale.;The number of days patients participate in treatment. Timepoint: Before treatment, After treatment, 3 months after treatment. Method of measurement: Counting the number of days of patients' participation in treatment.

—

Secondary

Measure	Time frame
Depression score. Timepoint: Before intervention, after intervention, 3 months after intervention. Method of measurement: Beck depression inventory- short form.;Quality of life score. Timepoint: Before intervention, after intervention, 3 months after intervention. Method of measurement: 36-Item Short Form Survey (SF-36).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Naseri

Shahed University

naseri@shahed.ac.ir+98 21 6646 4320

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026