None listed
Conditions
Brief summary
Over 35 million smokers try to quit smoking each year, yet less than 5% reach their 1-year anniversary. Numerous passive transdermal nicotine systems (reservoir and matrix) have been marketed over the past 13 years [i.e., Nicotrol (registered trademark), NicoDerm (registered trademark), CQ (registered trademark), Habitrol (registered trademark), ProStep (registered trademark), etc.]. These systems have been well characterized with regard to skin flux rates for nicotine Transdermal patches deliver 5 to 30 mg of nicotine over 24 hours, with the used patch still containing a significant amount of residual, undelivered nicotine. Chrono Therapeutics has developed an innovative programmable transdermal drug delivery system. The CQSS2 provides “off” periods (periods in which little to no nicotine is delivered), which is an advantage over existing systems that currently provide continuous delivery. Programmable drug delivery fulfills unmet medical needs in the treatment of critical diseases, based on the novel finding that patient compliance and medicinal efficacy can be enhanced with sequential bursts, or pulses, and are potentially more effective than traditional treatment regimens.
Interventions
Nicotine Replacement Therapy System, the CQSS2:
The treatment period consists of 2 weeks (14 days) of treatment. On the evening before each day of the treatment period, nicotine Drug Cartridges are inserted into the CQSS2 Control Unit. The subject enters, changes, or confirms the “Wake Time” in the Control Unit, which will determine when dosing begins on the following morning. The CQSS2 is then adhered to the upper arm, mid-thigh, calf, or torso based upon subject preference, and worn for appr
Nicotine Replacement Therapy System, the CQSS2: The treatment period consists of 2 weeks (14 days) of treatment. On the evening before each day of the treatment period, nicotine Drug Cartridges are inserted into the CQSS2 Control Unit. The subject enters, changes, or confirms the “Wake Time” in the Control Unit, which will determine when dosing begins on the following morning. The CQSS2 is then adhered to the upper arm, mid-thigh, calf, or torso based upon subject preference, and worn for approximately 20–24 hours. A new CQSS2 is applied each day for the 14 day treatment. One pouched Drug Cartridge will be used to administer 21 mg nicotine via a 5.4% w/v solution in an aqueous EtOH mixture per day. Metered pulses of 125 microliters 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. The mode of nicotine administration via the CQSS2 is transdermal. Subjects will be assigned to one of two treatment arms: Arm A (n=40): CQSS2; Arm B (n=40): NiQuitin (registered Trademark) Patch. The first 40 participants are enrolled into Arm B, and the next 40 participants are enrolled into Arm A. On the day after the last dose of study drug, subjects will return any unused CQSS2 Drug Cartridges, the CQSS2 Control Unit, and any unused NiQuitin (registered trademark) Patches. Data will be retrieved from the Ecological Momentary Assessment (EMA) device and drug accountability will be conducted.
Sponsors
Chrono Therapeutics Australia PTY LTD
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Smokers consuming on average more than or equal to 10 cigarettes per day for at least the past 6 months, confirmed by self report
Exclusion criteria
infections opiate use males who consume more than 4 alcoholic beverages per day females who consume more than 3 alcoholic beverages per day skin tattoos
Outcome results
None listed