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Evaluation of Learning-Theory-Based Smoking Cessation Strategies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Danielle E. McCarthy, Ph.D., Rutgers University
ClinicalTrials.gov Identifier:
NCT01368653
First received: June 6, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This clinical trials tests whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helps more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment being tested involves quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial will also test whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.


Condition Intervention
Nicotine Dependence
Behavioral: Standard treatment
Behavioral: Standard treatment+practice quitting
Drug: Very low nicotine cigarettes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • 4-week Abstinence [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 10-week Abstinence [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Mediators of Treatment Effects [ Time Frame: 1 week post-quit and 6 weeks post-quit ] [ Designated as safety issue: No ]
    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 of the first phase treatment. Additional analyses of reports of emotions, thoughts, and behaviors will explore mediators of non-nicotine cigarette effects on smoking. These measures will be analyzed to see if treatment affects them and if they predict smoking behavior.

  • Prolonged Abstinence [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.


Enrollment: 93
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard treatment
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
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
Other Name: Nicotine patch
Experimental: Standard treatment+practice quitting
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.
Behavioral: 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
Other Name: Nicotine patch
Experimental: Very low nicotine cigarettes
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
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.
No Intervention: Advice and encouragement only
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368653

Locations
United States, New Jersey
Rutgers University Institute for Health, Health Care Policy, and Aging Research
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Danielle E McCarthy, Ph.D. Rutgers University
  More Information

Additional Information:
No publications provided

Responsible Party: Danielle E. McCarthy, Ph.D., Associate Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT01368653     History of Changes
Other Study ID Numbers: DA026511, 1R21DA026511-01A1
Study First Received: June 6, 2011
Results First Received: November 7, 2014
Last Updated: November 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers University:
Tobacco
Smoking
Smoking Cessation
Tobacco Dependence
Tobacco Use
Nicotine Dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014