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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA021619-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Practice Quit Attempt plus Nicotine Replacement Therapy |
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| 2 | Active Comparator | Practice Quit Attempt only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Quit Attempt plus nicotine lozenge | Other | nicotine lozenge, 2 mg or 4 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 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 | Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt. | From study enrollment through six month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Carpenter, Ph.D. | Medical University of South Carolina | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22123796 | Derived | Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492. |
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Participants were randomized to treatment group in a 1:1 ratio using a random number generator with block randomization before research staff made calls to initiate formal study enrollment.
Participants were recruited from 1/2009 - 2/2010 via the internet from an email database of potential enrollees provided by a market research firm. Eligible participants were mailed an informed consent and asked to return a signed copy if they wished to participate. Research staff then made calls to initiate formal study enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Practice Quit Attempt Plus Nicotine Replacement Therapy | This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. |
| FG001 | Practice Quit Attempt Only | This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Practice Quit Attempt Plus Nicotine Replacement Therapy | This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. |
| BG001 | Practice Quit Attempt Only |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 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. | All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. | Posted | Number | participants | From study enrollment through six month follow-up |
|
Adverse events were collected in the Practice Quit Attempt (PQA) + Nicotine Replacement Therapy (NRT) group only. They were collected at every follow-up study visit, which included 5 time points over a 7.5 month (32 weeks) period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Practice Quit Attempt Plus Nicotine Replacement Therapy | This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Renal and urinary disorders | Non-systematic Assessment | We were notified of the death of a participant from bladder cancer in the control group(PQA Only group, did not receive nicotine replacement therapy) by the participant's wife. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/stomach upset (dyspepsia) | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew J. Carpenter | Medical University of South Carolina' | 843-792-3974 | carpente@musc.edu |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Practice Quit Attempt only | Behavioral | Practice Quit Attempts (PQA) message aided by brief advice and self-help materials |
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| At 6-month follow-up |
This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Practice Quit Attempt Only |
This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). |
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| Secondary | Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. | Posted | Number | participants | At any point during the study |
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| Primary | A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | Serious quit attempt of >=24hrs, which fits the CDC's definition of a quit attempt. | All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. | Posted | Number | participants | From study enrollment through six month follow-up |
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| Secondary | Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit. | Posted | Number | participants | At 6-month follow-up |
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| 0 |
| 426 |
| 179 |
| 426 |
| EG001 | Practice Quit Attempt Only | This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA). | 1 | 423 | 0 | 0 |
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| Throat irritation | General disorders | Non-systematic Assessment |
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| Hiccups | General disorders | Non-systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
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