Tobacco Use DisorderNCT02265367
Novel Medication as a Potential Smoking Cessation Aid
A study testing Levomilnacipran 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 provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Levomilnacipran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2017
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 25 years old and 55 years old
- Smoke a minimum number of cigarettes per day
- Indicate motivation to quit smoking
Who cannot join
- Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication
- Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran
- Are pregnant or breast feeding
- The investigators will evaluate if there are other reasons why someone may not be eligible to 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 provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.
- Conditions
- Tobacco Use Disorder
- Being tested
- Levomilnacipran, Placebo
- 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.
LevomilnacipranDrug
Also called Fetzima
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Levomilnacipran | Experimental | In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated Receives: Drug: Levomilnacipran; Drug: Placebo |
| Placebo | Experimental | In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated Receives: Drug: Levomilnacipran; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- NCT02265367
- Sponsor's protocol ID
- 1409M53561
- Status last verified
- Mar 2022
- First submitted
- 9 Oct 2014
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Medication as a Potential Smoking Cessation Aid
- ClinicalTrials.gov ID
- NCT02265367
- Acronym / sponsor ID
- 1409M53561
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Posted 22 Apr 2022
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 provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levomilnacipran | Experimental | Drug: Levomilnacipran, Drug: PlaceboIn the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated |
| Placebo | Experimental | Drug: Levomilnacipran, Drug: PlaceboIn the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be between 25 years old and 55 years old
- Smoke a minimum number of cigarettes per day
- Indicate motivation to quit smoking
Key exclusion criteria (4 listed)
- Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication
- Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran
- Are pregnant or breast feeding
- The investigators will evaluate if there are other reasons why someone may not be eligible to 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 |
|---|---|---|
| LevomilnacipranAlso: Fetzima | Drug | Levomilnacipran, Placebo |
| Placebo | Drug | Levomilnacipran, Placebo |
Primary outcome
Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
Time frame: 5 days
Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Levomilnacipran 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 3 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 22 Apr 2022. 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. 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 22 Apr 2022). 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?
Percent of Days of Confirmed Abstinence (Out of 5 Maximum) (time frame: 5 days). 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 22 Apr 2022.