SmokingNDSNCT00108342
Nicotine Delivery Systems: Research & Treatment
A study testing Nicotine gum - 2 mg and 4 mg, Nicotine lozenges - 2 mg and 4 mg and Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing in people with Smoking, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Nicotine gum - 2 mg and 4 mg, Nicotine lozenges - 2 mg and 4 mg and Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2009
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be enrolled veteran who smokes.
Who cannot join
- Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
- other criteria as determined by PI and study physicians
- reactions to menthol (inhaler) or to aspartame (lozenge)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: Nicotine Delivery Systems: Research and Treatment
The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.
Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.
Read the detailed description
The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.
- Conditions
- Smoking
- Being tested
- Nicotine gum - 2 mg and 4 mg, Nicotine lozenges - 2 mg and 4 mg, Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing, Computer learning
- Keywords
- nicotine, drug therapy, Smoking Cessation
- 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.
Nicotine gum - 2 mg and 4 mgDrug
Also called Nicorette gum
Nicotine lozenges - 2 mg and 4 mgDrug
Also called Nicorette Commit lozenges
Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffingDrug
Also called Nicotrol
can yield 4 mg from 10 mg device - infrequent and frequent puffing
Computer learningOther
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Treatment (NRT) Sampling | Active comparator | Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device). Receives: Drug: Nicotine gum - 2 mg and 4 mg; Drug: Nicotine lozenges - 2 mg and 4 mg; Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing |
| NRT Computer Learning | Sham comparator | Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only Receives: Other: Computer learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Attempts, Use of NRTs, Preference Among NRTs
In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.
Measured: At testing, at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionDec 2009
Why it stopped: Common comorbidities of Veterans precluded sufficient recruitment and enrollment.
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.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nina G. Schneider, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108342
- Sponsor's protocol ID
- NEUA-015-07S
- Acronym
- NDS
- Status last verified
- Jun 2014
- First submitted
- 14 Apr 2005
- Last updated
- 4 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Delivery Systems: Research and Treatment
- ClinicalTrials.gov ID
- NCT00108342
- Acronym / sponsor ID
- NDS / NEUA-015-07S
- Conditions
- Smoking
- Keywords
- nicotine, drug therapy, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Common comorbidities of Veterans precluded sufficient recruitment and enrollment.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Apr 2005 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.
Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.
Detailed description
The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Treatment (NRT) Sampling | Active comparator | Drug: Nicotine gum - 2 mg and 4 mg, Drug: Nicotine lozenges - 2 mg and 4 mg, Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffingSampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) 2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device). |
| NRT Computer Learning | Sham comparator | Other: Computer learningComputer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be enrolled veteran who smokes.
Key exclusion criteria (3 listed)
- Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
- other criteria as determined by PI and study physicians
- reactions to menthol (inhaler) or to aspartame (lozenge)
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 |
|---|---|---|
| Nicotine gum - 2 mg and 4 mgAlso: Nicorette gum | Drug | Nicotine Replacement Treatment (NRT) Sampling |
| Nicotine lozenges - 2 mg and 4 mgAlso: Nicorette Commit lozenges | Drug | Nicotine Replacement Treatment (NRT) Sampling |
| Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffingAlso: Nicotrolcan yield 4 mg from 10 mg device - infrequent and frequent puffing | Drug | Nicotine Replacement Treatment (NRT) Sampling |
| Computer learning | Other | NRT Computer Learning |
Primary outcome
Quit Attempts, Use of NRTs, Preference Among NRTs
Time frame: At testing, at follow-up
In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nina G. Schneider, PhD principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine gum - 2 mg and 4 mg, Nicotine lozenges - 2 mg and 4 mg and Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing in people with Smoking, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 Jun 2014). 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?
Quit Attempts, Use of NRTs, Preference Among NRTs (time frame: At testing, at follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2014.