Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Rutgers The State University of New Jersey

Status: Completed

Conditions: Nicotine Dependence

Treatments: Behavioral: Standard treatment; Behavioral: Standard treatment+practice quitting; Drug: Very low nicotine cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01368653

1R21DA026511-01A1 (U.S. NIH Grant/Contract)

DA026511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 4 patient groups

Standard treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard treatment

Standard treatment+practice quitting

Experimental group

Description:

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.

Treatment:

Behavioral: Standard treatment+practice quitting

Very low nicotine cigarettes

Experimental group

Description:

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

Treatment:

Drug: Very low nicotine cigarettes

Advice and encouragement only

No Intervention group

Description:

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.