Tobacco Use Disorder
Conditions
Brief summary
The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.
Interventions
DRUGNicotine lozenge
A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
Sponsors
National Institute on Drug Abuse (NIDA)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Smoking an average of at least 10 cigarette per day * General good health
Exclusion criteria
* unstable medical or psychiatric conditions * history of severe motion sickness * women who are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Craving | Baseline, 6 months | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges. |
| Nicotine Withdrawal Symptoms | 5 to 35 minutes | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Lozenge Immediately Prior to Stress Task. Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session | 22 |
| Nicotine Lozenge 10 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session | 22 |
| Nicotine Lozenge 20 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session | 22 |
| Nicotine Lozenge 30 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session | 18 |
| Total | 84 |
Baseline characteristics
| Characteristic | Nicotine Lozenge Immediately Prior to Stress Task. | Total | Nicotine Lozenge 30 Min Prior to Stress Task | Nicotine Lozenge 20 Min Prior to Stress Task | Nicotine Lozenge 10 Min Prior to Stress Task |
|---|---|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 10.6 | 38.3 years STANDARD_DEVIATION 12.9 | 37.9 years STANDARD_DEVIATION 14.1 | 38.1 years STANDARD_DEVIATION 16.2 | 39.7 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 20 Participants | 1 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 55 Participants | 14 Participants | 16 Participants | 11 Participants |
| Region of Enrollment United States | 22 participants | 84 participants | 18 participants | 22 participants | 22 participants |
| Sex: Female, Male Female | 8 Participants | 41 Participants | 9 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 43 Participants | 9 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 | 0 / 98 |
Outcome results
Primary
Craving
The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.
Time frame: Baseline, 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge Immediately Prior to Stress Task. | Craving | 5.17 units on a scale |
| Nicotine Lozenge 10 Min Prior to Stress Task | Craving | 2.45 units on a scale |
| Nicotine Lozenge 20 Min Prior to Stress Task | Craving | -1.05 units on a scale |
| Nicotine Lozenge 30 Min Prior to Stress Task | Craving | -1.34 units on a scale |
Primary
Nicotine Withdrawal Symptoms
The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.
Time frame: 5 to 35 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Nicotine Lozenge Immediately Prior to Stress Task. | Nicotine Withdrawal Symptoms | 2.1 units on a scale |
| Nicotine Lozenge 10 Min Prior to Stress Task | Nicotine Withdrawal Symptoms | 2.18 units on a scale |
| Nicotine Lozenge 20 Min Prior to Stress Task | Nicotine Withdrawal Symptoms | 0.32 units on a scale |
| Nicotine Lozenge 30 Min Prior to Stress Task | Nicotine Withdrawal Symptoms | 0.16 units on a scale |