N/A
N=56
Medicinal Nicotine for Preventing Cue Induced Craving
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02347605 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Craving Symptom Severity Score Assessed Via Questionnaire — 0.52; 0.57; 0.31 units on a scale — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine lozenge 4 mg (Drug); Placebo lozenge (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Craving Symptom Severity Score Assessed Via Questionnaire |
0.52; 0.57; 0.31 | 0.25 |
| PRIMARY Withdrawal Symptom Severity Score Assessed Via Questionnaire |
1.28; 0.96; 1.92 | 0.18 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02347605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.