Effectiveness of Different THR Products in Adult Population
Study Details
Study Description
Brief Summary
The study is a two-arm, double blind, 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 include both genders of at least 18 years of age, self-identified as regular smokers (≥10 cigarettes per day for at least one year) and motivated to quit. Participants will complete a total of ten visits including screening visit and baseline visit along with eight study visits. Participants will complete telephone follow-ups at weeks 1, 2, 8 and 18. They will come to site for screening visit, baseline line visit and study visits at weeks 4, 12, 24, and 52. Biochemically validated smoking abstinence will be measured at trial site using exhaled carbon monoxide (exhaled carbon monoxide ≥ 10 ppm will be considered an indicator of current smoking). At all follow-up calls and visits, information about self-reported smoking, e-cigarette/nicotine patch use, use of other smoking cessation therapies, withdrawal symptoms, and side effects will be collected.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The W3-030 Trial is a two-arm, double blind, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks. Participants will be recruited from the general population through outpatient, and/or walk-in clinics, and/or through advertising. 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. Smoking cessation/relapse prevention counselling will be provided to both groups for a minimum of 30 minutes at baseline, 10 minutes during telephone follow-ups, and 15 minutes at trial site visits (20 minutes at week 4). Counselling will be administered by trained study personnel and based on the local or (international guidelines, if local guidelines not available) for tobacco use cessation counselling. Eligible participants include both gender of at least 18 years of age, self-identified as regular smokers (≥10 cigarettes per day for a least one year), and motivated to quit. A total of ten visits will be scheduled during the trial including a screening visit, a baseline (BL) visit and eight study visits (at weeks 1, 2, 4, 8, 12, 18, 24 and 52). Participants will complete telephone follow ups at weeks 1, 2, 8 and 18. Biochemically-validated smoking abstinence will be measured at trial site using exhaled carbon monoxide (exhaled carbon monoxide ≥ 10 ppm will be considered an indicator of current smoking). At all follow-up calls and visits, information about self-reported smoking, e-cigarette/nicotine patch use, use of other smoking cessation therapies, withdrawal symptoms, and side effects will be collected.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Study Arm A: Electronic Cigarettes (18mg/ml) Participants randomized to study arm A will be provided a free e-cigarette and sufficient nicotine cartridges (18 mg/ml) supply to last till next in person visit. Participants will be instructed to use the device ad libitum one week before their quit day to familiarize themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the e-cigarette exclusively for the next 12 weeks. The usual recommended dose and dosage regimen suggest that each vaping session to last approximately 10 puffs, with one puff every 30 seconds over a span of approximately 4.5 minutes |
Device: E-Cigarette
Rechargeable e-cigarettes may be used for an indefinite amount of time, as the product battery is recharged using a computer USB port or wall outlet. In this case, the user replaces the atomizer cartridge or refills the chamber as frequently as necessary.
|
| Active Comparator: Study Arm B: 21 mg nicotine patches Participants randomized to study arm B will be provided 21 mg nicotine patches supply to last till next in person visit. Participants will use the nicotine patch daily for one week before their quit day to familiarize themselves with its use. On their designated quit day they will stop smoking and use nicotine patches daily for the next 12 weeks. Smokers who smoke more than 10 cigarettes per day (CPD) start with a 21-mg/day nicotine patch as recommended dose for quitting |
Drug: Nicotine patch
Transdermal nicotine patch formulations, applied daily, allow for ready nicotine absorption across the skin. Nicotine is slowly absorbed from patches and, on the first day, venous nicotine levels peak 6 to 10 hours post-administration. Thereafter, nicotine levels remain fairly steady with a decline from peak to trough of 25% to 40% with 24-hour patches. The patch is generally applied each 24 h for approximately 12 weeks or less but can be used for longer periods.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Biochemically-validated 7-day point prevalence smoking abstinence [12 weeks]
Biochemically-validated 7-day point prevalence smoking abstinence assessed through exhaled CO measurements of ≤ 10 ppm.
Secondary Outcome Measures
- Seven-day point prevalence [7 days for 12 weeks]
Number of Participants who self-report having smoked no cigarettes (not even a puff ) in the past 7 days
- Use of tobacco combustible cigarettes [12 weeks]
Number of cigarettes smoked per day assessed using self reported diaries and mobile application tracker
- Perception of the product [12 weeks]
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.
- Adverse events [12 weeks]
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.
- Physical signs and symptoms associated with withdrawal [52 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Both genders of at least 18 years of age
-
Smoked at least 10 cigarettes a day for the past one year
-
Exhaled breath CO (eCO) level > 10 ppm
-
Motivated to quit smoking or wishing to do so in the next 30 days according to Motivation to Stop Scale (MTSS) level 5 or higher
-
Able to understand and provide informed consent
-
Have a mobile phone
-
Able to comply with all
Exclusion Criteria:
-
Pregnant and breastfeeding women
-
Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline)
-
Clients of a smoking cessation program or enrolled in another trial
-
Any female participant who becomes pregnant during this study
-
Contraindications to nicotine patches (i.e, they have had a heart attack, stroke or severe angina within the previous 2weeks) or e-cigarette (i.e, they self-report a history of severe allergies and/or poorly controlled asthma)
-
Major illness with a prognosis of ≤ 1 year will also be excluded
-
Medical/psychiatric history except those having disease prognosis with less than one year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South East Hospital and Research Centre | Islamabad | Federal | Pakistan | 44000 |
Sponsors and Collaborators
- Foundation for a Smoke Free World INC
Investigators
- Principal Investigator: Madeeha Malik, PhD, Cyntax Health Projects PVT LTD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- W3-030