Tobacco Use DisorderNCT02347605
Medicinal Nicotine for Preventing Cue Induced Craving
A study testing Nicotine lozenge 4 mg in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Nicotine lozenge 4 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Smoking a minimum number of cigarettes per day
- General good health
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- Nicotine lozenge 4 mg, Placebo lozenge
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine lozenge 4 mgDrug
Placebo lozengeDrug
| Study group | Role | What they receive |
|---|---|---|
| Nicotine lozenge 4 mg prior to cue exposure | Experimental | Nicotine lozenge is used 15 minutes prior to smoking cue exposure Receives: Drug: Nicotine lozenge 4 mg |
| Placebo lozenge prior to cue exposure | Placebo comparator | Placebo lozenge is used 15 minutes prior to smoking cue exposure Receives: Drug: Placebo lozenge |
| Control condition: Lozenge after cue exposure | Other | Lozenge is used immediately after smoking cue exposure Receives: Drug: Nicotine lozenge 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kotlyar, PharmD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347605
- Sponsor's protocol ID
- WS2385492
- Status last verified
- Dec 2017
- First submitted
- 14 Jan 2015
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicinal Nicotine for Preventing Cue Induced Craving
- ClinicalTrials.gov ID
- NCT02347605
- Acronym / sponsor ID
- WS2385492
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine lozenge 4 mg prior to cue exposure | Experimental | Drug: Nicotine lozenge 4 mgNicotine lozenge is used 15 minutes prior to smoking cue exposure |
| Placebo lozenge prior to cue exposure | Placebo comparator | Drug: Placebo lozengePlacebo lozenge is used 15 minutes prior to smoking cue exposure |
| Control condition: Lozenge after cue exposure | Other | Drug: Nicotine lozenge 4 mgLozenge is used immediately after smoking cue exposure |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Smoking a minimum number of cigarettes per day
- General good health
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kotlyar, PharmD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine lozenge 4 mg in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving Symptom Severity Score Assessed Via Questionnaire (time frame: approximately 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.