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Effect of oral naloxone on constipation of patients treated by opium tincture

Double-blind placebo-controlled randomized clinical trial on the use of oral naloxone on constipation of patients treated by opium tincture

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190207042648N3
Enrollment
120
Registered
2021-02-16
Start date
2021-05-22
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Drug induced constipation. Constipation

Interventions

Intervention 1: Intervention group 1: The blinded therapists of HRCs delivers 7 coded capsules contain 2 mg Naloxan ( Sigma ) after initial evaluation ( for seven days ). The capsuled were filled b

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Participants that are in the opium tincture treatment in the 5 first months. Willingness to participate in research studies. Receiving the average dose of the opium tincture less than 10 CC in the last month. Age between 20 - 50 years.

Exclusion criteria

Exclusion criteria: Past history of GI surgery History of Thyroid disease History of Diabetes Hypercalcemia Renal failure Using Tricyclic antidepressant Using Calcium Chanel blockers Hypertension Cardiac disease Multi-drugs abuser Using anticholinergic drugs Pregnancy Recently sever weight loss more than 4 NVD or past history of severe labor Parkinsonism

Design outcomes

Primary

MeasureTime frame
Constipation score. Timepoint: At the start of treatment , one and two weeks later (end of research). Method of measurement: CONSTIPATION SCORING SYSTEM and Briston scoring.;Defecation in the three areas of abdominal, rectal and feces. Timepoint: At the start of treatment , one and two weeks later (end of research). Method of measurement: PAC-SYM questionnaire.

Secondary

MeasureTime frame
Opiate withdrawal scoring. Timepoint: 24 hours after starting the treatment patients were evaluated by phone call. One and two weeks later ( end of research) were scored. Method of measurement: opiate withdrawal scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Moshiri

Mashhad University of Medical Sciences

moshirim@mums.ac.ir+98 51 3854 3031

Outcome results

None listed

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