Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial. - Rapid Reduction Study

Phase 1

• Conditions: Smoking and nicotine addiction.; MedDRA version: 9.1 Level: LLT Classification code 10056478 Term: Nicotine addiction; MedDRA version: 9.1 Level: LLT Classification code 10056484 Term: Nicotine craving; MedDRA version: 9.1 Level: LLT Classification code 10057852 Term: Nicotine dependence; MedDRA version: 9.1 Level: LLT Classification code 10008374 Term: Cessation of smoking; MedDRA version: 9.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy

• Registration Number: EUCTR2008-006433-28-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

1.males and females 18 years or older,
2.smokes at least 15 cigarettes or 12.5g of loose tobacco daily as roll your own cigarettes, or blows 15 or15ppm or above on CO recording.
3.willing to stop smoking completely in two weeks
4.evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate and be randomised to either arm
5.be willing and able to comply with all study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. currently using other NRT, bupropion, nortriptyline, mecamylamine, reserpine, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture),
2. unstable angina pectoris, myocardial infarction, or cerebrovascular accident during the last 3 weeks,
3. severe cardiac arrhythmia
4. currently uncontrolled hyperthyroidism
5. active phaeocromocytoma
6. pregnancy, lactation or intended pregnancy
7. suspected alcohol or drug abuse
8. participation in other medicinal trials within the last three months and during study participation,
9. previously had severe skin reactions to nicotine patches or severe eczema or other skin diseases that make patch use hazardous or undesirable.
10. a severe acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To ascertain whether reducing cigarette smoking 2 weeks before a specified quit date (rapid reduction), with behavioral and NRT support, leads to better, worse or equal 4 week abstinence outcome as abrupt quitting on a specified quit date with no reduction, but also with behavioural and NRT support in the 2 weeks prior to quit date. ;<br> Secondary Objective: To monitor daily smoking and NRT use, cigarette satisfaction (mCEQ), smoking in those that lapse, urges and withdrawal (MPSS), self-efficacy, exhaled carbon monoxide (CO), and salivary cotinine throughout the trial.<br><br> To look at abstinence outcome at 8 week follow up.<br><br> To look at smoking status and NRT use over the past 5 months at 6 month follow up.<br><br> To find out participants views of the quitting method they used and whether they think this could be improved<br> ;Primary end point(s): Measure of abstinence at 6 month follow up.