NCT01522963

Brief Summary

The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 11, 2017

Completed
Last Updated

August 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

January 17, 2012

Results QC Date

February 13, 2017

Last Update Submit

July 20, 2017

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Craving

    The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.

    Baseline, 6 months

  • Nicotine Withdrawal Symptoms

    The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.

    5 to 35 minutes

Study Arms (4)

Nicotine Lozenge Immediately Prior to Stress task

EXPERIMENTAL

Subjects will receive the nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session

Drug: Nicotine lozenge

Nicotine lozenge 10 Minutes prior to Stress task

EXPERIMENTAL

Subjects will receive the nicotine lozenge after the stress task during one laboratory session and immediately prior to the stress task at the other laboratory session

Drug: Nicotine lozenge

Nicotine lozenge 20 minutes prior to Stress task

EXPERIMENTAL

Subjects will receive the nicotine lozenge after the stress task during one laboratory session and 10 minutes prior to the stress task at the other laboratory session

Drug: Nicotine lozenge

Nicotine Lozenge 30 minutes prior to stress taks

EXPERIMENTAL

Subjects will receive the nicotine lozenge 10 minutes prior to the stress task during one laboratory session and after the stress task at the other laboratory session

Drug: Nicotine lozenge

Interventions

Nicotine lozengeDRUG

A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Nicotine Lozenge 30 minutes prior to stress taksNicotine Lozenge Immediately Prior to Stress taskNicotine lozenge 10 Minutes prior to Stress taskNicotine lozenge 20 minutes prior to Stress task

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoking an average of at least 10 cigarette per day
  • General good health

You may not qualify if:

  • unstable medical or psychiatric conditions
  • history of severe motion sickness
  • women who are pregnant or breast feeding
  • The investigators will evaluate if there are other reasons why someone may not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Kotlyar M, Lindgren BR, Vuchetich JP, Le C, Mills AM, Amiot E, Hatsukami DK. Timing of nicotine lozenge administration to minimize trigger induced craving and withdrawal symptoms. Addict Behav. 2017 Aug;71:18-24. doi: 10.1016/j.addbeh.2017.02.018. Epub 2017 Feb 10.

    PMID: 28235705DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Michael Kotlyar
Organization
University of Minnesota
kotly001@umn.edu
6126251160

Study Officials

  • Michael Kotlyar, PharmD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

February 1, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 21, 2017

Results First Posted

July 11, 2017

Record last verified: 2017-07

Locations

US(1)