Clinical trial NCT01368653
Conditions: Nicotine Dependence
Keywords: Tobacco Smoking Smoking Cessation Tobacco Dependence Tobacco Use Nicotine Dependence
Sponsor: Rutgers University
Start date: 2012-06-01; Completion date: 2013-08-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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 arm 2: 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. arm 3: 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 arm 4: 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.
Interventions: intervention 1: Standard treatment intervention 2: Standard treatment+practice quitting intervention 3: Very low nicotine cigarettes
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: 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.

Protocol documents: