Drug abuse treatment is a major health and social problem in Iran with 5 to 10% successful abstinence in reports. As all of drug users are smoker, quitting smoking may increase the rate of success according to international studies. For the first time in Iran this clinical trial is carried out in all clients admitted the drug rehabilitation centres. Subjects were randomly allocated into the intervention and control groups. The intervention group received 12 weeks of nicotine replacement and behaviour therapy. Both groups were followed for about a year. Nicotine replacement therapy was delivered in the form of nicotine patches in addition to methadone therapy in case group. 200 patients were recruited in each group after consenting to attend the study. Quitting smoking is the outcome measure that will be documented by CO expiratory test during follow-up
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802151878N1
Registration date:2010-10-12, 1389/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-12, 1389/07/20
Registrant information
Name
Gholamreza Heydari
Name of organization / entity
Tobacco Prevention & Control Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2010 6003
Email address
ghrheydari@nritld.ac.ir
Recruitment status
Recruitment complete
Funding source
Tobacco prevention and control research center
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding smoking cessation programs to drug abuse treatment in Tehran centers 2010
Public title
Evaluation of adding smoking cessation programs to drug abuse treatment in Tehran centers 2010
Purpose
Treatment
Inclusion/Exclusion criteria
Patients admitted to Tehran centers for drug rehabilitation and willing to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tobacco prevention and control research center
Street address
Niavaran, Drabad
City
Tehran
Postal code
19556
Approval date
2009-04-20, 1388/01/31
Ethics committee reference number
31-9
Health conditions studied
1
Description of health condition studied
quit smoking
ICD-10 code
f17
ICD-10 code description
Mental and behavioural disorders due to tobacco use
Primary outcomes
1
Description
quit smoking
Timepoint
1-3-6-12 month
Method of measurement
co expiratory test - self report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nicotine replacement therapy for 12 weeks ( nicotine patch 7, 14, 21, mg for 3 weeks each followed by 3 weeks nicotine gum
Category
Treatment - Drugs
2
Description
Control group: did not receive Nicotine Replacement therapy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Smoking Cessation Clinic
Full name of responsible person
Anahita Alvanpour
Street address
No 2, Pirozi St, Charsad dasgah
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National research institute of TB and lung diseases
Full name of responsible person
Dr Mohammad Varahram
Street address
Niavaran-Darabad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National research institute of TB and lung diseases
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tobacco Prevention and Control Research Center
Full name of responsible person
Gholamreza Heydari
Position
Director
Other areas of specialty/work
Street address
Darabad
City
Tehran
Postal code
19556
Phone
+98 21 2010 6003
Fax
+98 21 2010 6003
Email
ghrheydari@nritld.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tobacco Prevention and Control Research Center
Full name of responsible person
Gholamreza Heydari
Position
MD
Other areas of specialty/work
Street address
Darabad
City
Tehran
Postal code
19556
Phone
+98 21 2010 6003
Fax
+98 21 2010 6003
Email
ghrheydari@nritld.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tobacco Prevention and Control Research Center
Full name of responsible person
Gholamreza Heydari
Position
Director
Other areas of specialty/work
Street address
Darabad
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)