SmokingNCT00706979
A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
A study testing Practice Quit Attempt plus nicotine lozenge and Practice Quit Attempt only in people with Smoking and Smoking Cessation, run by Medical University of South Carolina.
Trial summary
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: 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Practice Quit Attempt plus nicotine lozenge and Practice Quit Attempt only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 849 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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).
Read more
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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Practice Quit Attempt plus nicotine lozenge, Practice Quit Attempt only
- Keywords
- smoking, smoking cessation, nicotine replacement therapy
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice Quit Attempt plus nicotine lozengeOther
Also called Nicotine lozenge, Nicotine Replacement Therapy (NRT)
nicotine lozenge, 2 mg or 4 mg
Practice Quit Attempt onlyBehavioural
Practice Quit Attempts (PQA) message aided by brief advice and self-help materials
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Practice Quit Attempt plus Nicotine Replacement Therapy Receives: Other: Practice Quit Attempt plus nicotine lozenge |
| 2 | Active comparator | Practice Quit Attempt only Receives: Behavioral: Practice Quit Attempt only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From study enrollment through six month follow-up
Secondary outcomes (2)
Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days
Measured: 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
Measured: At 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Matthew J Carpenter, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706979
- Sponsor's protocol ID
- 1R01DA021619-01A1
- Other IDs
- 1R01DA021619-01A1
- Status last verified
- Oct 2010
- First submitted
- 26 Jun 2008
- Last updated
- 9 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22123796
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
- ClinicalTrials.gov ID
- NCT00706979
- Acronym / sponsor ID
- 1R01DA021619-01A1
- Conditions
- Smoking, Smoking Cessation
- Keywords
- smoking, smoking cessation, nicotine replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Posted 9 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Practice Quit Attempt plus nicotine lozengePractice Quit Attempt plus Nicotine Replacement Therapy |
| 2 | Active comparator | Behavioral: Practice Quit Attempt onlyPractice Quit Attempt only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice Quit Attempt plus nicotine lozengeAlso: Nicotine lozenge, Nicotine Replacement Therapy (NRT)nicotine lozenge, 2 mg or 4 mg | Other | 1 |
| Practice Quit Attempt onlyPractice Quit Attempts (PQA) message aided by brief advice and self-help materials | Behavioural | 2 |
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22123796Carpenter 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Carpenter, Ph.D. principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Practice Quit Attempt plus nicotine lozenge and Practice Quit Attempt only in people with Smoking and Smoking Cessation, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (time frame: From study enrollment through six month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00706979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2011.