Drug Addiction, Drug Dependence, Nicotine Addiction, Substance Use Disorder, Tobacco Dependence
Conditions
Keywords
Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
Brief summary
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
Detailed description
The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.
Interventions
DEVICETreatment A with device Clickotine® (Active intervention)
The intervention regimen around Treatment A is almost entirely user-directed. When a person has a craving, a series of options are available to ease the craving and resist the urge to smoke. The user will also engage with Clickotine® leading up to their quit date to complete a program of 21 Missions, daily activities which help prepare them to quit and keep them off cigarettes. Ideally, the user will open and use Treatment A several times a day.
DEVICETreatment B with smoking education (control)
The Treatment B app is operated by the National Cancer Institute to provide education and support to smokers seeking to quit. The QG regimen is entirely user-directed. When a user has a craving or wants support or education, they can log into the QG app. The QG app also provides lessons relevant for preparing to quit and beginning to quit.
Sponsors
Click Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 65 2. Smokes at least 5 cigarettes daily 3. Is interested in quitting in the next 30 days 4. Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher 5. Willing and able to receive SMS text messages 6. Able to comprehend the English-language and the informed consent form 7. Lives in the United States 8. One half of the study sample will be recruited from the general population of smokers via social media advertisements 9. One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network
Exclusion criteria
1. Prior use of Clickotine or QuitGuide 2. Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure: | [Time Frame: 8 week core study] | The primary objective is to confirm the improved efficacy of CKT for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs. QuitGuide. \*\*Acceptance criteria: Self-reported 30 day point prevalence quit rates will be significantly higher in the CKT arm than QuitGuide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | [Time Frame: 8 week core study] | A secondary objective of the study is to establish the feasibility of biochemical verification of smoking cessation in a fully remote, digital clinical trial. |
Countries
United States
Outcome results
None listed