Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use (DUAL)
Nicotine Addiction, Cigarette Smoking
About this trial
This is an interventional basic science trial for Nicotine Addiction
Eligibility Criteria
Inclusion Criteria:
- Subject is healthy as judged by the Investigator based on all available assessments from the Screening Period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
- Subject smokes on average four days a week for the last 12 months.
- Subject has no intention of quitting smoking within the next 90 days.
- Owns a smart phone with text message and data capabilities.
- Willingness to use and ability to operate e-cigarettes.
- Willingness to smoke Research Cigarettes.
Exclusion Criteria:
- Any medical or psychiatric condition (or associated symptoms or medications) determined by a medical professional to be severe enough to be disruptive to the study.
- Severe or uncontrolled psychiatric disease with the exception of anxiety disorders, obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder (ADHD);
- Pregnant or nursing (by self-report) or positive pregnancy test;
Daily use of:
- Experimental (investigational) drugs that are unknown to subject;
- Smokeless tobacco (chewing tobacco, snuff), cigars, pipes and hookah;
- e-cigarettes;
- Use in the past 30 days of nicotine replacement therapy or other smoking cessation product
- Positive drug screen for cocaine
Sites / Locations
- Rose Research Center
- Rose Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
0.40mg Nicotine Cigarette w/ e-Cigarette
1.40mg Nicotine Cigarette w/ e-Cigarette
2.50mg Nicotine Cigarette w/ e-Cigarette
5.60mg Nicotine Cigarette w/ e-Cigarette
16.9mg Nicotine Cigarette w/ e-Cigarette
Halo G6 & Tribeca e-liquid
Spectrum Research Cigarette
Participants will be assigned to smoke 0.40mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to JUUL e-cigarettes. Smoking research cigarettes with e-cigarette
Participants will be assigned to smoke 1.40mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to JUUL e-cigarettes. Smoking research cigarettes with e-cigarette
Participants will be assigned to smoke 2.50mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to JUUL e-cigarettes. Smoking research cigarettes with e-cigarette
Participants will be assigned to smoke 5.60mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to JUUL e-cigarettes. Smoking research cigarettes with e-cigarette
Participants will be assigned to smoke 16.9mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to JUUL e-cigarettes. Smoking research cigarettes with e-cigarette
Difference detection assessments. Nicotine discrimination thresholds
Difference detection assessments. Nicotine discrimination thresholds