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Medicinal Nicotine for Preventing Cue Induced Craving

NCT ID: NCT02347605

Last Updated: 2017-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nicotine lozenge 4 mg prior to cue exposure

Nicotine lozenge is used 15 minutes prior to smoking cue exposure

Group Type EXPERIMENTAL

Nicotine lozenge 4 mg

Intervention Type DRUG

Placebo lozenge prior to cue exposure

Placebo lozenge is used 15 minutes prior to smoking cue exposure

Group Type PLACEBO_COMPARATOR

Placebo lozenge

Intervention Type DRUG

Control condition: Lozenge after cue exposure

Lozenge is used immediately after smoking cue exposure

Group Type OTHER

Nicotine lozenge 4 mg

Intervention Type DRUG

Interventions

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Nicotine lozenge 4 mg

Intervention Type DRUG

Placebo lozenge

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kotlyar, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Clinical and Translational Sciences Institute

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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WS2385492

Identifier Type: -

Identifier Source: org_study_id