An interventional study of Practice Quit Attempt plus nicotine lozenge and Practice Quit Attempt only in Smoking and Smoking Cessation, sponsored by Medical University of South Carolina. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-09.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Practice Quit Attempt plus Nicotine Replacement Therapy
Other: Practice Quit Attempt plus nicotine lozenge
Practice Quit Attempt only
Behavioral: Practice Quit Attempt only
nicotine lozenge, 2 mg or 4 mg
Also known as: Nicotine lozenge, Nicotine Replacement Therapy (NRT)
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
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.
Time frame: 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.
Time frame: From study enrollment through six month follow-up
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
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
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.
| Milestone | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| Started | 426 | 423 |
| Completed | 426 | 423 |
| Not completed | 0 | 0 |
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.
| participants | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 208 | 168 |
| participants | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 82 | 63 |
Serious quit attempt of \>=24hrs, which fits the CDC's definition of a quit attempt.
| participants | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking | 185 | 143 |
| participants | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days | 68 | 57 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Practice Quit Attempt Plus Nicotine Replacement Therapy | — | 0/426 (0%) | 179/426 (42%) |
| Practice Quit Attempt Only | — | 1/423 (0.2%) | — |
| Event | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| DeathRenal and urinary disorders | 0/426 | 1/423 |
| Event | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only |
|---|---|---|
| Nausea/stomach upset (dyspepsia)Gastrointestinal disorders | 80/426 | — |
| Throat irritationGeneral disorders | 60/426 | — |
| HiccupsGeneral disorders | 45/426 | — |
| HeartburnGastrointestinal disorders | 23/426 | — |
| Age, Categorical(Participants) | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 382 | 389 | 771 |
| >=65 years | 44 | 34 | 78 |
| Age Continuous(years) | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only | Total |
|---|---|---|---|
| Mean | 50.5 ± 11.8 | 50.7 ± 11.4 | 50.6 ± 11.6 |
| Sex: Female, Male(Participants) | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only | Total |
|---|---|---|---|
| Female | 266 | 279 | 545 |
| Male | 160 | 144 | 304 |
| Region of Enrollment(participants) | Practice Quit Attempt Plus Nicotine Replacement Therapy | Practice Quit Attempt Only | Total |
|---|---|---|---|
| United States | 426 | 423 | 849 |
No study locations are listed for this record.
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Medical University of South Carolina