An interventional study of Nicotine lozenge 4 mg and Placebo lozenge in Tobacco Use Disorder, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-12-18.
Sponsored by University of Minnesota · Not applicable, Interventional, and Other
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 56 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The investigators will evaluate if there are other reasons why someone may not participate
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Drug: Nicotine lozenge 4 mg
Placebo lozenge is used 15 minutes prior to smoking cue exposure
Drug: Placebo lozenge
Lozenge is used immediately after smoking cue exposure
Drug: Nicotine lozenge 4 mg
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
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
| Milestone | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| Started | 10 | 10 | 8 | 10 | 9 | 9 |
| Completed lab 1 | 10 | 10 | 8 | 10 | 8 | 9 |
| Completed lab 2 | 7 | 7 | 7 | 7 | 6 | 8 |
| Completed | 7 | 7 | 7 | 6 | 6 | 7 |
| Not completed | 3 | 3 | 1 | 4 | 3 | 2 |
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.
| units on a scale | Nicotine Lozenge Prior to Cue Exposure | Placebo Lozenge Prior to Cue Exposure | Control Condition: Lozenge After Cue Exposure |
|---|---|---|---|
| Craving Symptom Severity Score Assessed Via Questionnaire | 0.52 ± 0.13 | 0.57 ± 0.13 | 0.31 ± 0.13 |
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.
| units on a scale | Nicotine Lozenge Prior to Cue Exposure | Placebo Lozenge Prior to Cue Exposure | Control Condition: Lozenge After Cue Exposure |
|---|---|---|---|
| Withdrawal Symptom Severity Score Assessed Via Questionnaire | 1.28 ± 0.39 | 0.96 ± 0.39 | 1.92 ± 0.39 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nicotine Lozenge Prior to Cue Exposure | — | 0/46 (0%) | 0/46 (0%) |
| Placebo Lozenge Prior to Cue Exposure | — | 0/46 (0%) | 0/46 (0%) |
| Control Condition: Lozenge After Cue Exposure | — | 0/45 (0%) | 0/45 (0%) |
| Age, Continuous(years) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 39.1 ± 12.1 | 45.9 ± 11.6 | 40.1 ± 16.6 | 37 ± 12.1 | 48.6 ± 12.3 | 48.7 ± 11.6 | 43.1 ± 13.0 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | 5 | 3 | 5 | 6 | 5 | 28 |
| Male | 6 | 5 | 5 | 5 | 3 | 4 | 28 |
| Race (NIH/OMB)(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 0 | 1 | 2 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 1 | 0 | 4 | 3 | 3 | 18 |
| White | 3 | 8 | 7 | 3 | 6 | 5 | 32 |
| More than one race | 0 | 1 | 1 | 1 | 0 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| United States | 10 | 10 | 8 | 10 | 9 | 9 | 56 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minnesota