Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Nicotine Dependence Clinical Trial

Official title: Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

• NCT number: NCT01368653
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Completion date: August 2013