A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
NCT ID: NCT00706979
Last Updated: 2011-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
849 participants
INTERVENTIONAL
2008-09-30
2010-10-31
Brief Summary
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1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
2. PQA aided by advice and self-help materials plus nicotine replacement therapy (NRT).
This study will test whether adding free nicotine replacement therapy to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. All treatments and assessments will be delivered via telephone and mailing. The primary outcome of interest is the incidence of a serious attempt to permanently stop smoking made over a six-month study period.
Our specific hypotheses are as follows:
Hypothesis 1: Helping smokers to make a practice quit attempt aided by NRT will result in a higher incidence of making a serious effort to quit smoking permanently, compared to an aided practice quit attempt without NRT. We also expect provision of NRT will increase point prevalence abstinence at 6 month follow-up.
Hypothesis 2: This relationship between NRT-aided practice quit attempts and quit behaviors will be mediated by a) increased smoking related self efficacy, b) increased belief in the efficacy of NRT, c) fewer concerns about adverse events of NRT, d) increased social support for not smoking, and e) less withdrawal distress and craving during the practice quit attempt.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Practice Quit Attempt plus Nicotine Replacement Therapy
Practice Quit Attempt plus nicotine lozenge
nicotine lozenge, 2 mg or 4 mg
2
Practice Quit Attempt only
Practice Quit Attempt only
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
Interventions
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Practice Quit Attempt plus nicotine lozenge
nicotine lozenge, 2 mg or 4 mg
Practice Quit Attempt only
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Interested in quitting at some time
* Not currently interested in quitting smoking
* Access to telephone (home or work) for 6 month study period
Exclusion Criteria
* Current pregnancy or breastfeeding
* Recent cardiovascular distress
* Phenylketonuria (PKU)
* Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Principal Investigators
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Matthew J Carpenter, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Countries
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References
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