Trial Outcomes & Findings for Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace (NCT NCT02951143)
NCT ID: NCT02951143
Last Updated: 2021-09-22
Results Overview
The Cigarette Purchase Task is a behavioral economic measure of abuse liability that consists of a series of hypothetical questions asking participants to indicate how many cigarettes they would purchase for their own consumption across a range of cigarette prices. Participants smoked one cigarette and then were asked to report how many cigarettes they would smoke within a 24 hour period at the following prices: $0.00 (free), $0.01, $0.05, $0.10, $0.25, $0.50, $1, $2, $5, $10, $25, $50, $100, $200. Nonlinear regression was then used to estimate the number of cigarettes participants would take when they were free using the equation by Koffarnus et al. (2015; doi:10.1037/pha0000045). The outcome is the logarithmically transformed number of cigarettes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
10 minutes after cigarette administration
Results posted on
2021-09-22
Participant Flow
Participant milestones
| Measure |
Single Arm
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
97
|
41
|
47
|
39
|
37
|
44
|
|
Overall Study
COMPLETED
|
36
|
32
|
29
|
30
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
61
|
9
|
18
|
9
|
6
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Each group (Various Concentrations and Single Arm) was analyzed separately.
Baseline characteristics by cohort
| Measure |
Single Arm
n=36 Participants
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
n=32 Participants
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
n=29 Participants
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
n=30 Participants
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
n=31 Participants
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
n=29 Participants
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Various Concentrations
|
—
|
41 years
n=32 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
37 years
n=29 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
46 years
n=30 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
42 years
n=31 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
39 years
n=29 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
41 years
n=151 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
|
Age, Continuous
Single Arm
|
38.5 years
n=36 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
—
|
—
|
—
|
—
|
—
|
38.5 years
n=36 Participants • Each group (Various Concentrations and Single Arm) was analyzed separately.
|
|
Sex: Female, Male
Female
|
15 Participants
n=36 Participants
|
16 Participants
n=32 Participants
|
12 Participants
n=29 Participants
|
16 Participants
n=30 Participants
|
15 Participants
n=31 Participants
|
13 Participants
n=29 Participants
|
87 Participants
n=187 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=36 Participants
|
16 Participants
n=32 Participants
|
17 Participants
n=29 Participants
|
14 Participants
n=30 Participants
|
16 Participants
n=31 Participants
|
16 Participants
n=29 Participants
|
100 Participants
n=187 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=36 Participants
|
21 Participants
n=32 Participants
|
19 Participants
n=29 Participants
|
20 Participants
n=30 Participants
|
24 Participants
n=31 Participants
|
17 Participants
n=29 Participants
|
128 Participants
n=187 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
9 Participants
n=36 Participants
|
7 Participants
n=32 Participants
|
9 Participants
n=29 Participants
|
9 Participants
n=30 Participants
|
7 Participants
n=31 Participants
|
10 Participants
n=29 Participants
|
51 Participants
n=187 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian
|
0 Participants
n=36 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=187 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=36 Participants
|
3 Participants
n=32 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=29 Participants
|
7 Participants
n=187 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
32 participants
n=32 Participants
|
29 participants
n=29 Participants
|
30 participants
n=30 Participants
|
31 participants
n=31 Participants
|
29 participants
n=29 Participants
|
187 participants
n=187 Participants
|
PRIMARY outcome
Timeframe: 10 minutes after cigarette administrationPopulation: Only those participants in the single arm completed this task.
The Cigarette Purchase Task is a behavioral economic measure of abuse liability that consists of a series of hypothetical questions asking participants to indicate how many cigarettes they would purchase for their own consumption across a range of cigarette prices. Participants smoked one cigarette and then were asked to report how many cigarettes they would smoke within a 24 hour period at the following prices: $0.00 (free), $0.01, $0.05, $0.10, $0.25, $0.50, $1, $2, $5, $10, $25, $50, $100, $200. Nonlinear regression was then used to estimate the number of cigarettes participants would take when they were free using the equation by Koffarnus et al. (2015; doi:10.1037/pha0000045). The outcome is the logarithmically transformed number of cigarettes.
Outcome measures
| Measure |
Single Arm
n=36 Participants
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
|---|---|---|---|---|---|---|
|
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
0.4mg/g
|
1.35 Cigarettes (log transformed)
Standard Error .0727
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
Usual Brand
|
1.50 Cigarettes (log transformed)
Standard Error .0583
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
15.8mg/g
|
1.45 Cigarettes (log transformed)
Standard Error .0555
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
5.2mg/g
|
1.47 Cigarettes (log transformed)
Standard Error .0538
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
2.4mg/g
|
1.45 Cigarettes (log transformed)
Standard Error .0678
|
—
|
—
|
—
|
—
|
—
|
|
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task
1.3mg/g
|
1.37 Cigarettes (log transformed)
Standard Error .0975
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Each session (6 sessions total) with at least 2 days between each session.Population: Only participants in the single arm had blood collected.
For participants in the single arm only, blood will be collected throughout each session and analyzed for nicotine content. The change in blood nicotine content over the course of the session will be compared among the six sessions where different cigarettes were administered. Blood nicotine (expressed in ng/mL) at minute 0 was subtracted from blood nicotine at minutes 10, 15, 20, 30, 45, and 60 to yield a change in blood nicotine (negative values were truncated to 0) at each of the time points. Using these change in blood nicotine values, we calculated Area Under the Curve (AUC) via the trapezoidal rule, which resulted in a singular number (total change in blood nicotine over the course of each experimental session) in our primary outcome measure.
Outcome measures
| Measure |
Single Arm
n=36 Participants
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
|---|---|---|---|---|---|---|
|
Change in Blood Nicotine Content Over the Course of the Session
Usual Brand
|
551.31 ng/mL/session
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Blood Nicotine Content Over the Course of the Session
15.8mg/g
|
350.62 ng/mL/session
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Blood Nicotine Content Over the Course of the Session
5.2mg/g
|
192.91 ng/mL/session
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Blood Nicotine Content Over the Course of the Session
2.4mg/g
|
57.11 ng/mL/session
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Blood Nicotine Content Over the Course of the Session
1.3mg/g
|
30.18 ng/mL/session
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
|
Change in Blood Nicotine Content Over the Course of the Session
0.4mg/g
|
6.24 ng/mL/session
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Sessions 2-5 with each session conducted one week apart (for 4 weeks total)Population: This single arm did not complete the Experimental Marketplace Purchases
In all arms except the single arm, measures of quantities of experimental cigarettes and other nicotine products will be obtained.
Outcome measures
| Measure |
Single Arm
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
n=32 Participants
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
n=29 Participants
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
n=30 Participants
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
n=31 Participants
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
n=29 Participants
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
|---|---|---|---|---|---|---|
|
Experimental Marketplace Purchases
Current Marketplace
|
—
|
4.07 grams of nicotine from non-cigarettes
Standard Error 3.13
|
12.29 grams of nicotine from non-cigarettes
Standard Error 3.47
|
15.25 grams of nicotine from non-cigarettes
Standard Error 3.26
|
13.67 grams of nicotine from non-cigarettes
Standard Error 3.19
|
15.25 grams of nicotine from non-cigarettes
Standard Error 3.31
|
|
Experimental Marketplace Purchases
Proposed Marketplace
|
—
|
12.70 grams of nicotine from non-cigarettes
Standard Error 3.13
|
25.54 grams of nicotine from non-cigarettes
Standard Error 3.47
|
17.42 grams of nicotine from non-cigarettes
Standard Error 3.26
|
16.92 grams of nicotine from non-cigarettes
Standard Error 3.19
|
14.93 grams of nicotine from non-cigarettes
Standard Error 3.31
|
|
Experimental Marketplace Purchases
Combined Marketplace (Usual Brand Increasing)
|
—
|
4.58 grams of nicotine from non-cigarettes
Standard Error 3.13
|
11.27 grams of nicotine from non-cigarettes
Standard Error 3.47
|
8.34 grams of nicotine from non-cigarettes
Standard Error 3.26
|
13.30 grams of nicotine from non-cigarettes
Standard Error 3.19
|
7.17 grams of nicotine from non-cigarettes
Standard Error 3.31
|
|
Experimental Marketplace Purchases
Combined Marketplace (Experimental Cigarette Increasing)
|
—
|
3.50 grams of nicotine from non-cigarettes
Standard Error 3.13
|
9.62 grams of nicotine from non-cigarettes
Standard Error 3.47
|
8.81 grams of nicotine from non-cigarettes
Standard Error 3.26
|
11.36 grams of nicotine from non-cigarettes
Standard Error 3.19
|
6.67 grams of nicotine from non-cigarettes
Standard Error 3.31
|
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.4 mg/g Concentration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1.3 mg/g Concentration
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
2.4 mg/g Concentration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5.2 mg/g Concentration
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
15.8 mg/g Concentration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=97 participants at risk
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
n=41 participants at risk
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
n=47 participants at risk
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
n=39 participants at risk
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
n=37 participants at risk
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
n=44 participants at risk
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
Social circumstances
Life Events
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.7%
1/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
Surgical and medical procedures
Gall Bladder removal
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.7%
1/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
Other adverse events
| Measure |
Single Arm
n=97 participants at risk
All participants will complete the same experimental events across 6 laboratory sessions.
SPECTRUM cigarettes: Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
|
0.4 mg/g Concentration
n=41 participants at risk
Participants in this arm will experience the 0.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
1.3 mg/g Concentration
n=47 participants at risk
Participants in this arm will experience the 1.3 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
2.4 mg/g Concentration
n=39 participants at risk
Participants in this arm will experience the 2.4 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
5.2 mg/g Concentration
n=37 participants at risk
Participants in this arm will experience the 5.2 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
15.8 mg/g Concentration
n=44 participants at risk
Participants in this arm will experience the 15.8 mg/g Concentration
SPECTRUM cigarettes between: Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
|
|---|---|---|---|---|---|---|
|
Social circumstances
Life events
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.3%
1/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
General disorders
Nausea
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
|
Gastrointestinal disorders
Vomit after cigarette and alcohol consumption
|
0.00%
0/97 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/41 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
2.1%
1/47 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/39 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/37 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
0.00%
0/44 • Adverse event data were collected during the approximately 5 weeks of participation for participants in the various concentration groups (all arms other than the single arm). Adverse event data were collected during the approximately 2 months of participation for individuals in the single arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place