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IRCT20181026041468N4 IRCT 2021-08-11 Arak University of Medical Sciences Comparison of efficacy of Varenicline and transcranial direct current stimulation (tDCS) in smoke cessation Comparison of efficacy of Varenicline and transcranial direct current stimulation (tDCS) in smoke cessation 2021-07-21 anticipated 106 Complete https://irct.ir/trial/56753 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study restricted randomization method is used, which in order to create a balance in the samples assigned to each of the study groups, we will use the block randomization method with quadruple blocks. First the required blocks are numbered using a table of random numbers. Each block is assigned 2 samples for intervention and 2 samples for control. The samples for the intervention group (tDCS) are called A and the samples for the control group (receiving varenicline tablets) are called B. Then the sequence of these samples (A and B) for each block is determined using sequence generation software called (Random Allocation Software) RAS and finally based on the number of blocks and sequences assigned to each block is determined that Samples belong to intervention group A (tDCS) or control group B (receiving varenicline tablets). For concealment, blocking and allocation sequence is done by a person not involved in the research. 4 Nicotine dependence. Intervention 1: In the intervention group, 10 sessions of 2 milliampere stimulation of tDCS will be done for 20 minutes every day. Intervention 2: In the control group, the varenicline tablets will be prescribed for 6 weeks, starting from half of milligram daily from the first day to 3rd and will be continued on the day 4th to 7th for half milligram every 12 hours, and 1 milligram every 12 hours from the 8th day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information is available
public Mehran Shayganfard
Amirkabir hospital, Alamolhoda St.
Arak Iran (Islamic Republic of) 381961187 +98 86 3313 4715 mshayganfard@yahoo.com Arak University of Medical Sciences scientific Mehran Shayganfard
Amirkabir hospital, Alamolhoda St.
Arak Iran (Islamic Republic of) 381961187 +98 86 3313 4715 mshayganfard@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Smokers at the age of 18-65 Having a minimum literacy Informed consent 18 years 65 years Both Request from the patient or the patient's legal guardian to leave the study at any time of the study Occurrence of harmful or intrusive side effects due to Varenicline or tDCS Any contraindications of tDCS Epilepsy Dementia, delirium or other cognitive disorders Any history of psychiatric disorders Severe smoking Any history of attempting to smoke cessation including, Varenicline or Bupropion tablets, Nicotine gum and nicotine patch F17.21 Nicotine dependence, cigarettes Treatment - Devices Treatment - Drugs In the intervention group, 10 sessions of 2 milliampere stimulation of tDCS will be done for 20 minutes every day. In the control group, the varenicline tablets will be prescribed for 6 weeks, starting from half of milligram daily from the first day to 3rd and will be continued on the day 4th to 7th for half milligram every 12 hours, and 1 milligram every 12 hours from the 8th day. Smoke cessation. Timepoint: Beginning and the end of the intervention. Method of measurement: Nicotine dependence scale (NDSS). Arak University of Medical Sciences Approved 2021-04-21 کمیته اخلاق دانشگاه علوم پزشکی اراک Deputy of research and technology, Arak university of medical sciences, Payambar Azam university complex. Arak Markazi Iran (Islamic Republic of)