Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Nicotine Dependence Clinical Trial

Official title:

Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368653
• Other study ID #: DA026511
• Secondary ID: 1R21DA026511-01A
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Standard treatment
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
• Standard treatment+practice quitting
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

Drug:
• Very low nicotine cigarettes
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.

Locations

Country	Name	City	State
United States	Rutgers University Institute for Health, Health Care Policy, and Aging Research	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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