Smoking CessationPhase 4NCT00625794
Nicotine Replacement and Counseling In Adolescents
A Phase 4 study testing Nicotine nasal spray and Smoking cessation counseling in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine nasal spray and Smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be between 15 and 18 years-old
- Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.
Who cannot join
- Adolescents who were using or had used nicotine replacement in the prior week were excluded.
- Those who used bupropion (Zyban®) within the past 30 days were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers
The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine nasal spray, Smoking cessation counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine nasal sprayDrug
8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed).
Smoking cessation counselingBehavioural
8 weeks or counseling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 8 weeks or counseling plus 6 weeks of nicotine nasal spray Receives: Drug: Nicotine nasal spray |
| 2 | Active comparator | 8 weeks or counseling only. Receives: Behavioral: Smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.
Measured: 12 weeks
Secondary outcomes (1)
Acceptability of the Nicotine Nasal Spray by Adolescents.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startSep 2005
- Primary completionMay 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Mark Rubinstein, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625794
- Sponsor's protocol ID
- 1K23RR018471
- Other IDs
- 1K23RR018471
- Status last verified
- May 2007
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Nicotine Nasal Spray in Adolescent Smokers
- ClinicalTrials.gov ID
- NCT00625794
- Acronym / sponsor ID
- 1K23RR018471
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pilot study is to determine the feasibility and utility of using the nicotine nasal spray (NNS) in adolescent smokers who want to quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nicotine nasal spray8 weeks or counseling plus 6 weeks of nicotine nasal spray |
| 2 | Active comparator | Behavioral: Smoking cessation counseling8 weeks or counseling only. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Be between 15 and 18 years-old
- Smoke 5 or more cigarettes per day (cpd) for at least 6 months and want to quit smoking.
Key exclusion criteria (2 listed)
- Adolescents who were using or had used nicotine replacement in the prior week were excluded.
- Those who used bupropion (Zyban®) within the past 30 days were also excluded.
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 nasal spray8 weeks or counseling plus 6 weeks of nicotine nasal spray (2 sprays each nostril as needed). | Drug | 1 |
| Smoking cessation counseling8 weeks or counseling | Behavioural | 2 |
Primary outcome
Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine.
Time frame: 12 weeks
1 secondary outcome
Acceptability of the Nicotine Nasal Spray by Adolescents.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2008.
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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.
Mark Rubinstein, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine nasal spray and Smoking cessation counseling in people with Smoking Cessation, run by University of California, San Francisco 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 2 inclusion and 2 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 28 Feb 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported smoking abstinence verified by both expired-air carbon monoxide and salivary cotinine. (time frame: 12 weeks). 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 28 Feb 2008.