Smoking CessationPhase 2NCT03178422
Safety and Efficacy Study of the NRT CQSS2 System for Smoking Cessation in Treatment-Seeking Subjects
A Phase 2 study testing CQSS2 and NicoDerm CQ Patch in people with Smoking Cessation, run by Chrono Therapeutics, Inc. at 5 sites in United States.
Trial summary
Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin. They have been found to reduce craving, thereby enhancing a patient's success for quitting smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- CQSS2 and NicoDerm CQ Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2017to 31 Oct 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for study participation, subjects must meet the following inclusion criteria:
- Ability to participate fully in all aspects of the study.
- Ability to understand and sign the study informed consent form.
- English-speaking, literate males and females.
- Age ≥18 years.
- Smokers consuming on average >10 cigarettes per day for the past 6 months, confirmed by self report.
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- Carbon monoxide (CO) level ≥10 ppm, as determined by a Smokerlyzer breath test.
- Subject is in good health as determined by the Investigator.
- Subject has no known issues with completing all study visits.
- Subject must have regular access to Verizon Wireless at home as verified by www.opensignal.com or www.sensorly.com, at home wifi, or known connectivity to Verizon Wireless.
Who cannot join
- Subjects will be excluded from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Subjects with screening clinical laboratory tests (complete blood count [CBC] with differential and platelets, and chemistry profile) outside the normal range and considered to be clinically significant by the Investigator.
- Subjects with severe hepatic, renal, cardiovascular, endocrine, or hematologic diseases who demonstrate abnormal electrolyte, hematology, and/or liver function (albumin, total protein, bilirubin) results on the screening blood laboratory tests, or with a history or illness that may (in the opinion of the Investigator) confound the results of the study or pose additional risk. Because these disorders may occur either alone or in combination, this judgment is left to the discretion of the Investigator caring for the subject.
- Subjects who are immunocompromised; have an infection or suspected infection with tuberculosis (TB) or hepatitis C virus (HCV); or have a suspected infection with, or history of, human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
- Subjects with positive screening urine test for drugs of abuse, including opiates, amphetamines, barbiturates, methadone, oxycodone, benzodiazepines, cocaine, phencyclidine, methamphetamine, ecstasy, or cannabinoids; or with a history of use of cocaine, heroin, recreational drugs (e.g., MDMA/"ecstasy"), methamphetamine, or hallucinogens at any time during the past 3 months; or use of marijuana on a weekly basis for the past 3 months.
- Subjects with recent history (past 3 months) of abuse of, or dependence on, a substance other than tobacco, including: heavy alcohol consumption (i.e., if male, drinking >4 alcoholic beverages per day for the past month and, if female, drinking >3 alcoholic beverages per day for the past month).
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- Subjects with physical examination (PE) abnormal findings considered to be clinically significant by the Investigator.
- Subjects with tattoos that could interfere with skin assessments.
- Subjects with any sign of infection, dermatologic disease, or condition that would inhibit transdermal absorption or might interfere with the evaluation of a test site reaction in locations where the investigational product may be used; or infection or condition (e.g., respiratory infection, strep throat) that would prevent full participation in the study.
- Electrocardiogram (ECG) readings outside the normal range and considered to be clinically significant by the Investigator.
- Subjects with:
- moderately severe or severe depression, as defined by a Patient Health Questionnaire (PHQ-9) total score of ≥10, or
- suicidal ideation, as defined by a PHQ-9 score ≥1 in response to question 9, "Thoughts that you would be better off dead, or of hurting yourself."
- Subjects with a history of psychosis, bipolar disorder, suicide attempt, schizophrenia, or any other significant psychiatric history that the Investigator believes may interfere with the subject's participation in the study.
- Subjects who have used an antipsychotic medication within the past 30 days. Subjects may be enrolled into the study if currently on a stable dose of antidepressant for the past 30 days and the dose is not expected to change throughout the duration of the study.
- Subjects who require any medications that may interfere with the absorption, metabolism, or excretion of the study drug.
- Subjects who have had a known reaction to nicotine replacement therapy (NRT) products or components.
- Subjects who score <6 on the Visual Analogue Scale (VAS) for Motivation to Quit Smoking.
- Women who are, or intend to become, pregnant during the course of this study, are currently breastfeeding, or women who refuse to use at least one method of birth control for the duration of the study.
- Subjects who have used any treatments for tobacco dependence within the past 30 days.
- Subjects who have used an investigational drug within the past 30 days or are involved in an ongoing clinical study.
- Subjects who plan on using forms of nicotine other than cigarettes (e.g., e-cigarettes, smokeless tobacco) throughout the duration of the clinical study.
- Subjects with a history of illness that may (in the opinion of the Investigator) confound the results of the study or pose additional risk.
- Subjects with another household member or known relative participating in the study.
- Subjects who have participated and been treated in any previous Chrono Therapeutics clinical study.
- Subjects who work third shift or who otherwise stay awake all night and sleep during daylight hours.
- Subjects who do not have access to the internet (access can be through a personal computer, smartphone, library computer, etc.).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
Central Kentucky Research Associates, LLC
Lexington, Kentucky, 40509
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Clinical Research Consortium
Tempe, Arizona, 85283
About this study
Official title: Open-Label, Multicenter Study Evaluating the Safety and Efficacy of the Nicotine Replacement Therapy Chrono Quit Smoking Solution (CQSS2) System (21mg) Compared to the NicoDerm® CQ® Patch (21mg) for Smoking Cessation in Treatment Seeking Subjects
Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin. They have been found to reduce craving, thereby enhancing a patient's success for quitting smoking. However, side effects such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are commonly experienced by users of such systems. Chrono Therapeutics, Inc. has developed an innovative programmable transdermal drug delivery system called the Chrono Quit Smoking Solution (CQSS2) that provides "off" periods (periods in which little to no nicotine is delivered), which is an advantage over existing systems that currently provide continuous delivery. The most important features of the CQSS2 are the periodic automatic dosing, plus the reduced side effects of sleep disturbances and potentially, skin irritation. The period when less nicotine is being delivered through the skin allows the skin an opportunity to "recover", thereby potentially reducing skin irritation. Another major benefit is the automatic dosing, which provides higher drug dosage at specific times of the day, leading to potentially greater success in quitting smoking. In this study, the CQSS2 will be used in conjunction with the Digital Coach application (app). The Digital Coach is a custom mobile app that provides behavioral support for the CQSS2. Together, the CQSS2 and the Digital Coach comprise the CQSS2 System.
Read the detailed description
Study EF2016-003 is a Phase 2, randomized, two-arm, open-label, multicenter efficacy and safety study of the CQSS2 System for smoking cessation over a 6-week treatment period in healthy treatment-seeking subjects who are smokers.
PRIMARY OBJECTIVES:
To evaluate quit rates (continuous abstinence from smoking during the last 4 weeks of treatment [Visit 3 through the end of study treatment]) in smokers (more than 10 cigarettes/day) being treated with the CQSS2 System versus NicoDerm® CQ® patch
SECONDARY OBJECTIVES:
To assess the safety and tolerability of the CQSS2 System
- Conditions
- Smoking Cessation
- Being tested
- CQSS2, NicoDerm CQ Patch
- Keywords
- tobacco use cessation, smoking prevention, NRT
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CQSS2Drug
Also called Chrono Quit Smoking Solution
Nicotine Replacement Therapy
NicoDerm CQ PatchDrug
Also called Nicotine patch
Nicotine Replacement Therapy
| Study group | Role | What they receive |
|---|---|---|
| CQSS2 System (nicotine 21 mg) | Experimental | Active CQSS2 System (nicotine 21 mg) with Digital Coach. One active Drug Cartridge will be used to transdermally administer 21 mg nicotine via a 5.4% w/v solution in an aqueous EtOH mixture per day. Metered pulses of 125 µL of solution will automatically be delivered by the assembled CQSS2 (containing the Control Unit and Drug Cartridge) at Time = 0, 0.5, 1, 7, 7.5, and 13 hours. Receives: Drug: CQSS2 |
| NicoDerm® CQ® patch (21 mg) | Active comparator | NicoDerm® CQ® patch (21 mg) with committedquitters.com. The NicoDerm patch transdermally administers 21 mg of nicotine per day. The NicoDerm patch is applied each morning of the treatment period after waking and worn for approximately 24 hours. Receives: Drug: NicoDerm CQ Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Rates for Smokers treated with the CQSS2 System vs NicoDerm CQ Patch
Quit rates will be assessed by subject self-reporting, confirmed by Smokerlyzer testing, and documented by the Tobacco Outcome Measures Assessment. The Smoking Self Efficacy Questionnaire (SEQ12) will measure the subject's perceived ability to quit smoking.
Measured: continuous abstinence from smoking during the last 4 weeks of treatment [Visit 3 through the end of study treatment]) in smokers (more than 10 cigarettes/day)
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed on an 8-point Skin Irritation Assessment scale (0 to 7)
Any score of ≥3 will be reported as an AE
Measured: From the time of the study drug application (6 week study period) until the last Follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start7 Aug 2017
- Primary completion18 Oct 2017
- Study completion31 Oct 2017
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- combination product
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chrono Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allen Wyler, MD, Study director, Chrono Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178422
- Sponsor's protocol ID
- EF2016-003
- Status last verified
- Nov 2017
- First submitted
- 21 Apr 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter Study Evaluating the Safety and Efficacy of the Nicotine Replacement Therapy Chrono Quit Smoking Solution (CQSS2) System (21mg) Compared to the NicoDerm® CQ® Patch (21mg) for Smoking Cessation in Treatment Seeking Subjects
- ClinicalTrials.gov ID
- NCT03178422
- Acronym / sponsor ID
- EF2016-003
- Conditions
- Smoking Cessation
- Keywords
- tobacco use cessation, smoking prevention, NRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Chrono Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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.
Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin. They have been found to reduce craving, thereby enhancing a patient's success for quitting smoking. However, side effects such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are commonly experienced by users of such systems. Chrono Therapeutics, Inc. has developed an innovative programmable transdermal drug delivery system called the Chrono Quit Smoking Solution (CQSS2) that provides "off" periods (periods in which little to no nicotine is delivered), which is an advantage over existing systems that currently provide continuous delivery. The most important features of the CQSS2 are the periodic automatic dosing, plus the reduced side effects of sleep disturbances and potentially, skin irritation. The period when less nicotine is being delivered through the skin allows the skin an opportunity to "recover", thereby potentially reducing skin irritation. Another major benefit is the automatic dosing, which provides higher drug dosage at specific times of the day, leading to potentially greater success in quitting smoking. In this study, the CQSS2 will be used in conjunction with the Digital Coach application (app). The Digital Coach is a custom mobile app that provides behavioral support for the CQSS2. Together, the CQSS2 and the Digital Coach comprise the CQSS2 System.
Detailed description
Study EF2016-003 is a Phase 2, randomized, two-arm, open-label, multicenter efficacy and safety study of the CQSS2 System for smoking cessation over a 6-week treatment period in healthy treatment-seeking subjects who are smokers.
PRIMARY OBJECTIVES:
To evaluate quit rates (continuous abstinence from smoking during the last 4 weeks of treatment [Visit 3 through the end of study treatment]) in smokers (more than 10 cigarettes/day) being treated with the CQSS2 System versus NicoDerm® CQ® patch
SECONDARY OBJECTIVES:
To assess the safety and tolerability of the CQSS2 System
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- combination product
| Arm | Type | Receives |
|---|---|---|
| CQSS2 System (nicotine 21 mg) | Experimental | Drug: CQSS2Active CQSS2 System (nicotine 21 mg) with Digital Coach. One active Drug Cartridge will be used to transdermally administer 21 mg nicotine via a 5.4% w/v solution in an aqueous EtOH mixture per day. Metered pulses of 125 µL of solution will automatically be delivered by the assembled CQSS2 (containing the Control Unit and Drug Cartridge) at Time = 0, 0.5, 1, 7, 7.5, and 13 hours. |
| NicoDerm® CQ® patch (21 mg) | Active comparator | Drug: NicoDerm CQ PatchNicoDerm® CQ® patch (21 mg) with committedquitters.com. The NicoDerm patch transdermally administers 21 mg of nicotine per day. The NicoDerm patch is applied each morning of the treatment period after waking and worn for approximately 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- To be eligible for study participation, subjects must meet the following inclusion criteria:
- Ability to participate fully in all aspects of the study.
- Ability to understand and sign the study informed consent form.
- English-speaking, literate males and females.
- Age ≥18 years.
Key exclusion criteria (27 listed)
- Subjects will be excluded from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed:
- Subjects with screening clinical laboratory tests (complete blood count [CBC] with differential and platelets, and chemistry profile) outside the normal range and considered to be clinically significant by the Investigator.
- Subjects with severe hepatic, renal, cardiovascular, endocrine, or hematologic diseases who demonstrate abnormal electrolyte, hematology, and/or liver function (albumin, total protein, bilirubin) results on the screening blood laboratory tests, or with a history or illness that may (in the opinion of the Investigator) confound the results of the study or pose additional risk. Because these disorders may occur either alone or in combination, this judgment is left to the discretion of the Investigator caring for the subject.
- Subjects who are immunocompromised; have an infection or suspected infection with tuberculosis (TB) or hepatitis C virus (HCV); or have a suspected infection with, or history of, human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
- Subjects with positive screening urine test for drugs of abuse, including opiates, amphetamines, barbiturates, methadone, oxycodone, benzodiazepines, cocaine, phencyclidine, methamphetamine, ecstasy, or cannabinoids; or with a history of use of cocaine, heroin, recreational drugs (e.g., MDMA/"ecstasy"), methamphetamine, or hallucinogens at any time during the past 3 months; or use of marijuana on a weekly basis for the past 3 months.
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 |
|---|---|---|
| CQSS2Also: Chrono Quit Smoking SolutionNicotine Replacement Therapy | Drug | CQSS2 System (nicotine 21 mg) |
| NicoDerm CQ PatchAlso: Nicotine patchNicotine Replacement Therapy | Drug | NicoDerm® CQ® patch (21 mg) |
Primary outcome
Quit Rates for Smokers treated with the CQSS2 System vs NicoDerm CQ Patch
Time frame: continuous abstinence from smoking during the last 4 weeks of treatment [Visit 3 through the end of study treatment]) in smokers (more than 10 cigarettes/day)
Quit rates will be assessed by subject self-reporting, confirmed by Smokerlyzer testing, and documented by the Tobacco Outcome Measures Assessment. The Smoking Self Efficacy Questionnaire (SEQ12) will measure the subject's perceived ability to quit smoking.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed on an 8-point Skin Irritation Assessment scale (0 to 7)
Time frame: From the time of the study drug application (6 week study period) until the last Follow-up visit.
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 4 Dec 2017.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Allen Wyler, MD study director
Chrono Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CQSS2 and NicoDerm CQ Patch in people with Smoking Cessation, run by Chrono Therapeutics, Inc. at 5 sites 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 10 inclusion and 27 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 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Quit Rates for Smokers treated with the CQSS2 System vs NicoDerm CQ Patch (time frame: continuous abstinence from smoking during the last 4 weeks of treatment [Visit 3 through the end of study treatment]) in smokers (more than 10 cigarettes/day)). 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 Dec 2017.