Clinical trial NCT01368653: Evaluation of Learning-Theory-Based Smoking Cessation Strategies
Official title: Evaluation of Learning-Theory-Based Smoking Cessation Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: Tobacco
Smoking
Smoking Cessation
Tobacco Dependence
Tobacco Use
Nicotine Dependence
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-08
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 4-week Abstinence
timeFrame: 4 weeks
Secondary outcomes:
measure: 10-week Abstinence
timeFrame: 10 weeks
measure: Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date
timeFrame: 3 weeks pre-quit
measure: Prolonged Abstinence
timeFrame: 10 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University Institute for Health, Health Care Policy, and Aging Research
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Danielle E McCarthy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: