SmokingPhase 1NCT01262170
A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
A Phase 1 study testing CigRx Lozenge and Tobacco Lozenge in people with Smoking and Tobacco Use Disorder, run by Rock Creek Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke Read more about this study
- Who is it for?
- Ages 23 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use Disorder
- What is being tested?
- CigRx Lozenge and Tobacco Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2010
- 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 smokers
- Smoking for at least 5 years
- Smoking at least one (1) pack of cigarettes a day
Who cannot join
- Allergy to lozenge components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke
A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke
Read the detailed description
Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.
- Conditions
- Smoking, Tobacco Use Disorder
- Being tested
- CigRx Lozenge, Tobacco Lozenge
- Keywords
- dietary supplement, nutraceutical
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CigRx LozengeDietary supplement
lozenge made of dietary supplements
Tobacco LozengeOther
lozenge made of compressed cured tobacco extract
| Study group | Role | What they receive |
|---|---|---|
| CigRx Lozenge | Experimental | CigRx Lozenge Receives: Dietary Supplement: CigRx Lozenge |
| Tobacco Lozenge | Active comparator | Tobacco Lozenge Receives: Other: Tobacco Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on subject's craving to smoke
craving is assessed by changes in questionnaire answers over time
Measured: 4 hours
Secondary outcomes (1)
Collection of information on adverse events related to study products
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rock Creek Pharmaceuticals, 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
- NCT01262170
- Sponsor's protocol ID
- RCP-002
- Status last verified
- Oct 2015
- First submitted
- 15 Dec 2010
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke
- ClinicalTrials.gov ID
- NCT01262170
- Acronym / sponsor ID
- RCP-002
- Conditions
- Smoking, Tobacco Use Disorder
- Keywords
- dietary supplement, nutraceutical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Dec 2010 (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.
A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke
Detailed description
Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CigRx Lozenge | Experimental | Dietary Supplement: CigRx LozengeCigRx Lozenge |
| Tobacco Lozenge | Active comparator | Other: Tobacco LozengeTobacco Lozenge |
Who may qualify
- Ages
- 23 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult smokers
- Smoking for at least 5 years
- Smoking at least one (1) pack of cigarettes a day
Key exclusion criteria (1 listed)
- Allergy to lozenge components
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 |
|---|---|---|
| CigRx Lozengelozenge made of dietary supplements | Dietary supplement | CigRx Lozenge |
| Tobacco Lozengelozenge made of compressed cured tobacco extract | Other | Tobacco Lozenge |
Primary outcome
Effect on subject's craving to smoke
Time frame: 4 hours
craving is assessed by changes in questionnaire answers over time
1 secondary outcome
Collection of information on adverse events related to study products
Time frame: 5 hours
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 30 Oct 2015.
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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 CigRx Lozenge and Tobacco Lozenge in people with Smoking and Tobacco Use Disorder, run by Rock Creek Pharmaceuticals, 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 3 inclusion and 1 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 30 Oct 2015. 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?
Effect on subject's craving to smoke (time frame: 4 hours). 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 30 Oct 2015.