Archive \ Volume.14 2023 Issue 4

Protocol for Randomized, Two Arm Parallel, Clinical Trial for Effectiveness of THR Products in LMIC

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LMICs bear an inexplicably larger share of the burden of tobacco-related death globally due to rising tobacco consumption. Understanding and conducting RCTs in the context of LMICs is mandatory to use THR products as an effective smoking cessation strategy for controlling rising tobacco consumption in these countries. The study is a two-arm, parallel RCT with a 12-week treatment period and a 52-week follow-up period which plans to enroll 258 smokers from general adult population. The participants after meeting eligibility criteria and providing informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counseling (2) Nicotine patches (21mg) with individual counseling. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face-to-face interactions at the trial site as well as follow-up on the telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence.

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How to cite:
Malik M, Hussain A, Hashmi A, Khan W. Protocol for Randomized, Two Arm Parallel, Clinical Trial for Effectiveness of THR Products in LMIC. Arch Pharm Pract. 2023;14(4):1-5.
Malik, M., Hussain, A., Hashmi, A., & Khan, W. (2023). Protocol for Randomized, Two Arm Parallel, Clinical Trial for Effectiveness of THR Products in LMIC. Archives of Pharmacy Practice, 14(4), 1-5.

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