Tobacco Use DisorderPhase 1NCT01337817
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
A Phase 1 study testing Ariva Silver Wintergreen and Ariva Wintergreen in people with Tobacco Use Disorder and Smoking, run by Star Scientific, Inc at 1 site in United States.
Trial summary
Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked. Read more about this study
- Who is it for?
- Ages 23 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking
- What is being tested?
- Ariva Silver Wintergreen and Ariva Wintergreen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2009
- Phase
- Phase 1
- 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 23 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adult smoker
- smoking for at least 5 years
- smoking at least one (1) pack of cigarettes a day
- interest in quitting smoking
Who cannot join
- known allergy to silver or silver salts
- pregnant or breast-feeding
- current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers
Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.
Read the detailed description
Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen lozenge on a random basis.
Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.
After a washout period, each subject will repeat the steps with the second type of lozenge.
- Conditions
- Tobacco Use Disorder, Smoking
- Being tested
- Ariva Silver Wintergreen, Ariva Wintergreen
- Keywords
- smoking, smokeless, aversion, nicotine, nicotine replacement
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ariva Silver WintergreenOther
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
Ariva WintergreenOther
Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Ariva Silver Wintergreen | Experimental | Subjects allow study product lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke. Receives: Other: Ariva Silver Wintergreen |
| Ariva Wintergreen | Active comparator | Subjects allow study comparator lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke. Receives: Other: Ariva Wintergreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Star Scientific, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Varga, MD, Principal investigator, Star Scientific, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337817
- Sponsor's protocol ID
- SSI-043
- Status last verified
- Oct 2014
- First submitted
- 14 Apr 2011
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers
- ClinicalTrials.gov ID
- NCT01337817
- Acronym / sponsor ID
- SSI-043
- Conditions
- Tobacco Use Disorder, Smoking
- Keywords
- smoking, smokeless, aversion, nicotine, nicotine replacement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Star Scientific, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Apr 2011 (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.
Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.
Detailed description
Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen lozenge on a random basis.
Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.
After a washout period, each subject will repeat the steps with the second type of lozenge.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ariva Silver Wintergreen | Experimental | Other: Ariva Silver WintergreenSubjects allow study product lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke. |
| Ariva Wintergreen | Active comparator | Other: Ariva WintergreenSubjects allow study comparator lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke. |
Who may qualify
- Ages
- 23 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy adult smoker
- smoking for at least 5 years
- smoking at least one (1) pack of cigarettes a day
- interest in quitting smoking
Key exclusion criteria (3 listed)
- known allergy to silver or silver salts
- pregnant or breast-feeding
- current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
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 |
|---|---|---|
| Ariva Silver WintergreenStudy product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose. | Other | Ariva Silver Wintergreen |
| Ariva WintergreenComparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose. | Other | Ariva Wintergreen |
Primary outcome
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
Time frame: 90 minutes
Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
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 24 Oct 2014.
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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.
Maria Varga, MD principal investigator
Star Scientific, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ariva Silver Wintergreen and Ariva Wintergreen in people with Tobacco Use Disorder and Smoking, run by Star Scientific, Inc 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 4 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: finished, as of the sponsor's last update on 24 Oct 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers (time frame: 90 minutes). 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 24 Oct 2014.