Tobacco Use DisorderPhase 1NCT01428310
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
A Phase 1 study testing Anatabloc(TM) and CigRx(R) in people with Tobacco Use Disorder and Tobacco Dependence, run by Rock Creek Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. 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, Tobacco Dependence, Smoking
- What is being tested?
- Anatabloc(TM) and CigRx(R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2011
- 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
- using at least 1 pack of cigarettes per day, for at least 5 years
Who cannot join
- allergy to study product components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension
This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.
- Conditions
- Tobacco Use Disorder, Tobacco Dependence, Smoking
- Being tested
- Anatabloc(TM), CigRx(R)
- Keywords
- dietary supplement, nutraceutical
- 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.
Anatabloc(TM)Dietary supplement
one dissolvable bit, one time, after a period of abstinence from smoking
CigRx(R)Dietary supplement
one dissolvable bit, one time, after a period of abstinence from smoking
| Study group | Role | What they receive |
|---|---|---|
| Anatabloc(TM) | Active comparator | dissolvable bit containing dietary ingredients, binders, fillers, and flavors Receives: Dietary Supplement: Anatabloc(TM) |
| CigRx(R) | Active comparator | dissolvable bit containing dietary ingredients, binders, fillers, and flavors Receives: Dietary Supplement: CigRx(R) |
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: 5 hours
Secondary outcomes (1)
adverse events related to study product
collection of information on adverse events related to study product
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 posted2 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionDec 2011
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
- Single blind
- Who is masked
- Participant
- 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
- NCT01428310
- Sponsor's protocol ID
- RCP-006
- Status last verified
- Oct 2015
- First submitted
- 1 Sep 2011
- 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 Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension
- ClinicalTrials.gov ID
- NCT01428310
- Acronym / sponsor ID
- RCP-006
- Conditions
- Tobacco Use Disorder, Tobacco Dependence, Smoking
- 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
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Sep 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.
This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatabloc(TM) | Active comparator | Dietary Supplement: Anatabloc(TM)dissolvable bit containing dietary ingredients, binders, fillers, and flavors |
| CigRx(R) | Active comparator | Dietary Supplement: CigRx(R)dissolvable bit containing dietary ingredients, binders, fillers, and flavors |
Who may qualify
- Ages
- 23 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adult smokers
- using at least 1 pack of cigarettes per day, for at least 5 years
Key exclusion criteria (1 listed)
- allergy to study product 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 |
|---|---|---|
| Anatabloc(TM)one dissolvable bit, one time, after a period of abstinence from smoking | Dietary supplement | Anatabloc(TM) |
| CigRx(R)one dissolvable bit, one time, after a period of abstinence from smoking | Dietary supplement | CigRx(R) |
Primary outcome
effect on subject's craving to smoke
Time frame: 5 hours
craving is assessed by changes in questionnaire answers over time
1 secondary outcome
adverse events related to study product
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 Anatabloc(TM) and CigRx(R) in people with Tobacco Use Disorder and Tobacco Dependence, 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 2 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: 5 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.