Tobacco Use Disorder
Conditions
Brief summary
The purpose of this study is to determine if changing the timeframe (relative to cue presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In this cross-over study, all subjects attend three laboratory sessions at which either nicotine lozenge or placebo is given prior to presentation of smoking cues or after presentation of smoking cues. The order in which the three conditions will be presented are randomized.
Interventions
DRUGNicotine lozenge 4 mg
DRUGPlacebo lozenge
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Smoking a minimum number of cigarettes per day * General good health
Exclusion criteria
* unstable medical or psychiatric conditions * history of severe motion sickness (due to virtual reality equipment used to present cues) * 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 Symptom Severity Score Assessed Via Questionnaire | approximately 15 minutes | Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure. |
| Withdrawal Symptom Severity Score Assessed Via Questionnaire | approximately 15 minutes | Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3 | 10 |
| Sequence 2 Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3 | 10 |
| Sequence 3 Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3 | 8 |
| Sequence 4 Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3 | 10 |
| Sequence 5 Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3 | 9 |
| Sequence 6 Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3 | 9 |
| Total | 56 |
Baseline characteristics
| Characteristic | Sequence 1 | Total | Sequence 6 | Sequence 5 | Sequence 4 | Sequence 3 | Sequence 2 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 12.1 | 43.1 years STANDARD_DEVIATION 13 | 48.7 years STANDARD_DEVIATION 11.6 | 48.6 years STANDARD_DEVIATION 12.3 | 37 years STANDARD_DEVIATION 12.1 | 40.1 years STANDARD_DEVIATION 16.6 | 45.9 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 18 Participants | 3 Participants | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 32 Participants | 5 Participants | 6 Participants | 3 Participants | 7 Participants | 8 Participants |
| Region of Enrollment United States | 10 participants | 56 participants | 9 participants | 9 participants | 10 participants | 8 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 28 Participants | 5 Participants | 6 Participants | 5 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 28 Participants | 4 Participants | 3 Participants | 5 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 46 | 0 / 45 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 | 0 / 45 |
Outcome results
Primary
Craving Symptom Severity Score Assessed Via Questionnaire
Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.
Time frame: approximately 15 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Lozenge Prior to Cue Exposure | Craving Symptom Severity Score Assessed Via Questionnaire | 0.52 units on a scale | Standard Error 0.13 |
| Placebo Lozenge Prior to Cue Exposure | Craving Symptom Severity Score Assessed Via Questionnaire | 0.57 units on a scale | Standard Error 0.13 |
| Control Condition: Lozenge After Cue Exposure | Craving Symptom Severity Score Assessed Via Questionnaire | 0.31 units on a scale | Standard Error 0.13 |
p-value: 0.25Mixed Models Analysis
Primary
Withdrawal Symptom Severity Score Assessed Via Questionnaire
Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure.
Time frame: approximately 15 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Lozenge Prior to Cue Exposure | Withdrawal Symptom Severity Score Assessed Via Questionnaire | 1.28 units on a scale | Standard Error 0.39 |
| Placebo Lozenge Prior to Cue Exposure | Withdrawal Symptom Severity Score Assessed Via Questionnaire | 0.96 units on a scale | Standard Error 0.39 |
| Control Condition: Lozenge After Cue Exposure | Withdrawal Symptom Severity Score Assessed Via Questionnaire | 1.92 units on a scale | Standard Error 0.39 |
p-value: 0.18Mixed Models Analysis