Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Study Overview
=================
Brief Summary
-----------------
This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.

Detailed Description
-----------------
Participants in this study are randomized to one of two treatments conditions prior to a target quit date. One-half of participants will be randomly assigned to receive standard smoking cessation treatment comprising a 6-week supply of 21-mg nicotine patches and 4 individual smoking cessation counseling sessions. The other one-half of participants will be randomly assigned to receive standard treatment (patch and counseling, as above) plus to practice quitting 7 times over the 2.5 weeks leading up to a quit attempt. Practice quitting will involve not smoking for a period of time tailored to each individual's smoking pattern. All participants are asked to attend a 2-hour orientation session, complete 8 brief (5-minute) telephone calls and 9 longer(20-minute) telephone surveys over 3.5 weeks, attend a 30-minute office visit, and complete two 15-minute follow-up calls. All participants are also asked to report on their emotions, thoughts, and behaviors 3 times per day for 24 days using cellular telephones. Participants receive compensation for office visits, study telephone calls, cellular telephone reports, and follow-up interviews. All participants will receive nicotine patches and one-on-one counseling (delivered over the phone and in person). Some participants will be eligible for a second phase of treatment after a 4-week follow-up interview. One-half of people eligible for this phase of the study will be randomly assigned to receive a supply of non-nicotine cigarettes to smoke for up to 6 weeks. The non-nicotine cigarettes are designed to help break the habit of smoking and to help smokers return to being smoke-free after smoking regular cigarettes. The other one-half of eligible smokers will be randomly assigned to not receive these non-nicotine cigarettes. All smokers eligible for this phase of the study will be asked to complete cellular telephone reports about their mood, thoughts, and behaviors for 14 days beginning 4.5 weeks after a target stop-smoking date. Compensation will be provided for completing these cellular telephone phone reports.

Official Title
-----------------
Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Behavioral: Standard treatment
* Behavioral: Standard treatment+practice quitting
* Drug: Very low nicotine cigarettes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Smoke cigarettes daily Motivated to quit smoking Able to read and write English Willing and able to complete study visits and cell phone calls Exclusion Criteria: Pregnancy, breastfeeding, planning on becoming pregnant during the study Recent heart attack or heart surgery, heart disease, unstable angina Allergy to adhesives Past negative reactions to nicotine patch Serious skin conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking | Behavioral: Standard treatment<br>* Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking<br>* Other names: Nicotine patch;|
| Experimental: Standard treatment+practice quitting<br>In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling. | Behavioral: Standard treatment+practice quitting<br>* This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling<br>* Other names: Nicotine patch;|
| Experimental: Very low nicotine cigarettes<br>In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this group. Those assigned to this group will receive a 6-week supply of cigarettes that contain tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment is designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking | Drug: Very low nicotine cigarettes<br>* This intervention will be offered to a subset of smokers from both of the other study arms. To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above. Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.<br>|
| No Intervention: Advice and encouragement only<br>In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this condition. Those in this arm will receive advice and encouragement to try to stop smoking again after they have slipped (returned to smoking) during a stop smoking attempt. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-week Abstinence | 7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-week Abstinence | This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million. | 10 weeks | 
| Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date | Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident. | 3 weeks pre-quit | 
| Prolonged Abstinence | This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt. | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco, Smoking, Smoking Cessation, Tobacco Dependence, Tobacco Use, Nicotine Dependence