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Completed

NCT Number: NCT01368653

Evaluation of Learning-Theory-Based Smoking Cessation Strategies

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University Institute for Health, Health Care Policy, and Aging Research

New Brunswick, New Jersey, 08901, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard treatment

Behavioral

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

Other names: Nicotine patch

Standard treatment+practice quitting

Behavioral

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

Other names: Nicotine patch

Very low nicotine cigarettes

Drug

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.

Primary outcomes

  1. 4-week Abstinence

    Time frame: 4 weeks

    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).

Secondary outcomes

  1. 10-week Abstinence

    Time frame: 10 weeks

    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.

  2. Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date

    Time frame: 3 weeks pre-quit

    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. Prolonged Abstinence

    Time frame: 10 weeks

    This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.

Sponsors and collaborators

Lead sponsor

Rutgers University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2011
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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