Medicinal Nicotine for Preventing Cue Induced Craving

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use Disorder

Treatments: Drug: Placebo lozenge; Drug: Nicotine lozenge 4 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02347605

WS2385492

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

Nicotine lozenge 4 mg prior to cue exposure

Experimental group

Description:

Nicotine lozenge is used 15 minutes prior to smoking cue exposure

Treatment:

Drug: Nicotine lozenge 4 mg

Placebo lozenge prior to cue exposure

Placebo Comparator group

Description:

Placebo lozenge is used 15 minutes prior to smoking cue exposure

Treatment:

Drug: Placebo lozenge

Control condition: Lozenge after cue exposure

Other group

Description:

Lozenge is used immediately after smoking cue exposure

Treatment:

Drug: Nicotine lozenge 4 mg