Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA048454 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
The purpose of the study is to evaluate how limiting the nicotine content in regular cigarettes affects choices for regular cigarette and e-cigarette products. Eligible participants will be of legal age to purchase tobacco products and regularly use both e-cigarettes and regular cigarettes.
Participants in this study will undergo an in-person screening session where the study will be explained in detail and participants will answer questions and provide a breath sample. During the screening session, participants will also be asked to complete surveys. Eligible participants will then complete the training procedures during which they will select an e-cigarette device to use for future preference sessions. During the 4 preference sessions, participants will sample puffs from an e-cigarette and regular cigarette and answer questions about their experience with each. They will also complete a task during which they can choose to earn puffs from the e-cigarette or regular cigarette, or choose to not take any puffs. The 4 sessions will be the same except that a different combination of e-cigarette and regular cigarette is used at each session.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study EC + UB CC | Active Comparator | Participants will make choices between the study e-cigarette (EC) device with tobacco flavor and their usual brand (UB) combusted cigarette (CC) |
|
| Study EC + NNC CC | Active Comparator | Participants will make choices between the study EC device with tobacco flavor and the normal nicotine content (NNC) investigational CC |
|
| Study EC + VLNC CC | Experimental | Participants will make choices between the study EC device with tobacco flavor and the very low nicotine content (VLNC) investigational CC |
|
| Own EC + UB CC | No Intervention | Participants will make choices between their own EC device with their own tobacco flavor and their UB CC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| very low nicotine content cigarettes | Other | Investigational combusted cigarettes with very low nicotine content |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of choices for CC during preference task | Participants will complete a preference task during which they will choose to take puffs from the session EC, the session CC, or to abstain from taking any puffs. A total of 10 trials will be completed. The number of choices for CC will be compared across the preference sessions. | during preference session, approximately 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of choices for EC during preference task | Participants will complete a preference task. The number of choices for EC will be compared across the preference sessions. | during preference session, approximately 2 hours |
| Number of choices to abstain during preference task |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Unstable medical conditions as determined by the licensed medical professional;
Unstable psychiatric conditions as determined by the licensed medical professional or PI;
Currently pregnant, breastfeeding, trying to become pregnant or unwilling to agree to use adequate protection to avoid pregnancy;
Serious quit attempt of either or both products in the past 3 months resulting in >30 days of abstinence;
Currently using nicotine replacement therapy or other pharmacotherapies as cessation aide;
Plans to quit use of either EC or CC, or all tobacco products in the next 45 days;
Self-reporting nicotine-free, CBD, or THC liquid is preferred or usual e-liquid;
Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
Allergy to propylene glycol or vegetable glycerin;
Previous adverse reaction when using vaping device or e-liquid;
Current or recent alcohol or drug abuse problems;
Previous use of SPECTRUM or other reduced nicotine content cigarettes in past 3 months;
Literate and able to independently complete and comprehend the consent form and other written study materials and measures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francis McClernon, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will complete 4 experimental sessions. At each session, they will receive a different combination of e-cigarette and combusted cigarette.
Not provided
Not provided
Not provided
Not provided
| normal nicotine content cigarettes | Other | Investigational combusted cigarettes with normal nicotine content |
|
|
| Study e-cigarette | Other | E-cigarette provided by study |
|
Participants will complete a preference task. The number of choices to abstain from any puffs will be compared across the preference sessions. |
| during preference session, approximately 2 hours |
| Cigarette Evaluation Scale | subjective reactions (e.g., satisfaction, dizziness) to CC product as well as how much a measure of how much they would pay for a day's worth of the product. Scale is administered on a 0-100 scale where 0 is "not at all" and 100 is "extremely" | during preference session, approximately 2 hours |
| Perceived health risk | Participants will rate on a scale from 1 (very low risk) to 7 (very high risk) their perceived risk of developing a variety of health conditions (e.g., lung cancer, heart disease, stroke) as a result of using each product. | during preference session, approximately 2 hours |
| Craving | craving rating on a scale from 1-10 [no urge to extremely strong urge] for CC and EC after product exposure relative to baseline value | during preference session, approximately 2 hours |
| Product Valuation | Participants will be asked how many days per month would they use the CC product they just sampled at a variety of price increments | during preference session, approximately 2 hours |
| CO boost | Breath carbon monoxide (CO) value after product exposure during the preference task relative to baseline value | during preference session, approximately 2 hours |
| Cross Price Elasticity | the change in demand for the session CC in response to a change in price of the session EC | during preference session, approximately 2 hours |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| D000072137 | Vaping |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided