Medicinal Nicotine for Preventing Cue Induced Craving

NCT02347605 | Completed Results

• 1 other identifier: WS2385492
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  approximately 15 minutes

Study Arms (3)

Nicotine lozenge 4 mg prior to cue exposure

EXPERIMENTAL

Nicotine lozenge is used 15 minutes prior to smoking cue exposure

Drug: Nicotine lozenge 4 mg

Placebo lozenge prior to cue exposure

PLACEBO COMPARATOR

Placebo lozenge is used 15 minutes prior to smoking cue exposure

Drug: Placebo lozenge

Control condition: Lozenge after cue exposure

OTHER

Lozenge is used immediately after smoking cue exposure

Drug: Nicotine lozenge 4 mg

Interventions

Nicotine lozenge 4 mg DRUG

Control condition: Lozenge after cue exposure; Nicotine lozenge 4 mg prior to cue exposure

Placebo lozenge DRUG

Placebo lozenge prior to cue exposure

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Smoking a minimum number of cigarettes per day
• General good health

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Michael Kotlyar
• Organization: University of Minnesota

kotly001@umn.edu

612-251-8780

Study Officials

• Michael Kotlyar, PharmD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 27, 2015
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 18, 2017
• Results First Posted: December 18, 2017

Record last verified: 2017-12

Locations

US (1)