A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions:
- Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current cigarette smoker of at least 10 cigarettes per day
- 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:
- Monthly cigar, pipe, or smokeless tobacco use
- Current pregnancy or breastfeeding
- Recent cardiovascular distress
- Phenylketonuria (PKU)
- Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Practice Quit Attempt plus Nicotine Replacement Therapy
|
nicotine lozenge, 2 mg or 4 mg
Other Names:
|
|
Active Comparator: 2
Practice Quit Attempt only
|
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
Time Frame: From study enrollment through six month follow-up
|
The primary outcome was an attempt to quit smoking for good.
To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good.
Quit attempts were defined as any self-defined attempt to quit for good.
|
From study enrollment through six month follow-up
|
|
A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking
Time Frame: From study enrollment through six month follow-up
|
Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt.
|
From study enrollment through six month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Time Frame: At any point during the study
|
At any point during the study
|
|
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Time Frame: At 6-month follow-up
|
At 6-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew J Carpenter, Ph.D., Medical University of South Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA021619-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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