Medicinal Nicotine for Preventing Cue Induced Craving
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Craving Symptom Severity Score Assessed Via Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Nicotine lozenge 4 mg prior to cue exposure
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Intervention: Nicotine lozenge 4 mg (Drug)
Placebo lozenge prior to cue exposure
Placebo lozenge is used 15 minutes prior to smoking cue exposure
Intervention: Placebo lozenge (Drug)
Control condition: Lozenge after cue exposure
Lozenge is used immediately after smoking cue exposure
Intervention: Nicotine lozenge 4 mg (Drug)
Outcomes
Primary Outcomes
Craving Symptom Severity Score Assessed Via Questionnaire
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported