Smoking Cessation Clinical Trial
Official title:
Randomized, Two Arm Parallel, Clinical Trial to Compare Effectiveness of Different Tobacco Harm Reduction Products in General Adult Population in Low Middle Income Countries
The study is a two-arm, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258 smokers from general adult population. Participants who meet the eligibility criteria and give their informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counselling (2) Nicotine patches (21mg) with individual counselling. Eligible participants must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. 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 interaction at trial site as well as follow up on 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. All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study.
Status | Not yet recruiting |
Enrollment | 258 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Both genders of legal age allowed for smoking as per country law - Smoked at least 10 cigarettes a day for the past one year - Exhaled breath CO (eCO) level > 10 ppm - Wish to quit smoking - Able to conform with all study procedures - Have a mobile phone - Expected to be available for follow up will be enrolled as study participants Exclusion Criteria: - Pregnant and breastfeeding women - Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline) - Having any contraindications to products such as cardiovascular history - Suffering from a major illness with prognosis of less than 1 year |
Country | Name | City | State |
---|---|---|---|
Pakistan | South East Hospital and Research Centre | Islamabad | Federal |
Lead Sponsor | Collaborator |
---|---|
Foundation for a Smoke Free World INC |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Point-prevalence abstinence | Number of participants self-reported abstinence in the past week, with biochemical validation using exhaled CO measurements of = 10 ppm. | 12 weeks | |
Secondary | Seven-day point prevalence | Number of Participants who self-report having smoked no cigarettes in the past 7 days | 7 days for 12 weeks | |
Secondary | Use of tobacco combustible cigarettes | Number of cigarettes smoked per day assessed using self reported diaries | 12 weeks | |
Secondary | Perception of the product | Participant views on using e-cigarettes or patches as a smoking cessation aid using Modified Cigarette Evaluation Questionnaire. The mCEQ consist of 12 questions for rating using Likert scale which ranges from 1 (not at all) to 7 (extremely). The answers are combined to form five unique subscales each made up of 1-5 items which quantify (1) Satisfaction, (2) Psychological Reward, (3) Enjoyment of Respiratory Tract Sensations, (4) Craving and (5) Aversion. Difference scores can range from -6 to +6 with positive scores indicating higher dose cigarette produce greater intensity of a subjective effect. | 12 weeks | |
Secondary | Adverse events | Adverse events related to e cigarettes and nicotine patches evaluated using Naranjo Adverse Drug Reaction Probability Scale. Total scores range from -4 to +13 with higher scores indicating definite adverse drug reaction; the reaction is considered definite and adverse reaction is present if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less. | 12 weeks | |
Secondary | Physical signs and symptoms associated with withdrawal | Physical sign and symptoms of withdrawal using Fagerstrom test for nicotine dependence. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are computed to yield a total score of 0-10. The higher the total Fagerstrom score, the more intense is the participant's physical dependence on nicotine. | 52 weeks |
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