Tobacco Use Disorder
Conditions
Brief summary
The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.
Interventions
DRUGFull Nicotine Cigarettes
A full nicotine tobacco cigarette that will be smoked by participants
A reduced nicotine tobacco cigarette that will be smoked by participants
BEHAVIORALAverage Nicotine Expectancy
Participant instructed the cigarette is the same level of nicotine as your usual brand.
BEHAVIORALVery Low Nicotine Expectancy
Participant instructed the cigarette is a very low level of nicotine compared to your usual brand.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 21 years or older * Smoke five or more cigarettes per day for the past six months * Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening
Exclusion criteria
* Intention to quit smoking in the next 30 days * Weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes * Serious medical or psychiatric disorder precluding participation by study physician guidance * Positive urine screening for illicit drugs other than cannabis or current substance use disorder * Women who are pregnant, plan to become pregnant, or are breast-feeding * Medical contraindications to receiving tobacco products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demand Intensity | Four times over approximately two weeks | Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome). |
| Demand Elasticity | Four times over approximately two weeks | Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale | Post-cigarette administration four times over approximately two weeks | A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Included in Analysis This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Subjects Included in Analysis |
|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 21 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Demand Elasticity
Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated)
Time frame: Four times over approximately two weeks
Population: Data are presented for all subjects with non-zero data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Included in Analysis | Demand Elasticity | Condition A: Told Full, Received Reduced | -1.31 log(cigarettes/dollar) | Standard Deviation 1.08 |
| Subjects Included in Analysis | Demand Elasticity | Condition B: Told Full, Received Full | -1.45 log(cigarettes/dollar) | Standard Deviation 0.5 |
| Subjects Included in Analysis | Demand Elasticity | Condition C: Told Reduced, Received Full | -1.57 log(cigarettes/dollar) | Standard Deviation 0.6 |
| Subjects Included in Analysis | Demand Elasticity | Condition D: Told Reduced, Received Reduced | -1.26 log(cigarettes/dollar) | Standard Deviation 1.17 |
Primary
Demand Intensity
Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome).
Time frame: Four times over approximately two weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Included in Analysis | Demand Intensity | Condition A: Told Full, Received Reduced | 6.48 cigarettes | Standard Error 4.55 |
| Subjects Included in Analysis | Demand Intensity | Condition B: Told Full, Received Full | 8.10 cigarettes | Standard Error 6.61 |
| Subjects Included in Analysis | Demand Intensity | Condition C: Told Reduced, Received Full | 7.81 cigarettes | Standard Error 5.63 |
| Subjects Included in Analysis | Demand Intensity | Condition D: Told Reduced, Received Reduced | 6.48 cigarettes | Standard Error 4.91 |
Secondary
Minnesota Nicotine Withdrawal Scale
A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome).
Time frame: Post-cigarette administration four times over approximately two weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Included in Analysis | Minnesota Nicotine Withdrawal Scale | Condition A: Told Full, Received Reduced | 5.67 units on a scale | Standard Deviation 6.95 |
| Subjects Included in Analysis | Minnesota Nicotine Withdrawal Scale | Condition B: Told Full, Received Full | 5.14 units on a scale | Standard Deviation 6.54 |
| Subjects Included in Analysis | Minnesota Nicotine Withdrawal Scale | Condition C: Told Reduced, Received Full | 4.33 units on a scale | Standard Deviation 4.95 |
| Subjects Included in Analysis | Minnesota Nicotine Withdrawal Scale | Condition D: Told Reduced, Received Reduced | 6.24 units on a scale | Standard Deviation 6.47 |