Investigation on the Effect of Hab-o-Shefa Product on craving Reduction after Detoxification Phase in Outpatients with Opioid Substance Use Disorder
Design
A double blind, with parallel groups, placebo controlled clinical trial
Settings and conduct
Patients receive weekly capsules after detoxification. At the beginning and monthly until the end of the study the outcome variables are measured through questionnaires. The capsules presented to patients are also coded by a third person and the research team members are not aware of the contents of the capsules.
Participants/Inclusion and exclusion criteria
Opioid Addiction According to DSM5 criteria, no history of major physical and mental illness, equal distribution on education, occupation, and marital status between samples, no addiction to other substances except opioid substances such as stimulants
Intervention groups
Both groups will receive coded capsules for 12 weeks. The intervention group will receive three capsules 500 mg Hab-o-Shefa Product daily orally for 3 months and the control group will receive three capsules 500 mg placebo daily orally for 3 months.
Main outcome variables
craving after Detoxification Phase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190817044547N1
Registration date:2019-10-01, 1398/07/09
Registration timing:registered_while_recruiting
Last update:2019-10-01, 1398/07/09
Update count:0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Mohammad Bagher Saberi zafarghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1658
Email address
saberi.mb@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Hab-o-Shefa Product on craving Reduction after Detoxification Phase in Outpatients with Opioid Substance Use Disorder
Public title
The Effect of Hab-o-Shefa Product on craving Reduction in Outpatients with Opioid Substance Use Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with opioid addiction according to the DSM V Reference Criteria who have not had other substance use disorders such as stimulants in the past year
People who can answer questions and tests
Blood pressure is lower than 14.9cm Hg;
There is not history of major physical and mental illness
There is an equal distribution on education, occupation, and marital status between samples.
Exclusion criteria:
Age
From 15 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Hab-o-Shefa Product and placebo were numbered by the third person