Tobacco Abstinence SyndromePhase 2NCT02028871
Intranasal Insulin for Weight Management During Smoking Cessation
A Phase 2 study testing Intranasal Insulin in people with Tobacco Abstinence Syndrome, run by Ajna Hamidovic at 2 sites in United States.
Trial summary
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Abstinence Syndrome
- What is being tested?
- Intranasal Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to May 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smokers (>10 cig/day) for the past 1 year
- normosmic olfactory function
Who cannot join
- previous/current use of insulin
- current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
- current pregnancy (or lactation)
- lifetime history of endocrine disease
- excessive alcohol use (>25 standard units of alcohol/week)
- current use of illicit drugs
Show all 9Show fewer
- current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent
- local infections, inflammation, structural abnormalities, or other nasal pathology
- current use of any medications administered intranasally, including intranasal steroids
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNM College of Pharmacy
Albuquerque, New Mexico, 87131
UNM College of Pharmacy
Albuquerque, New Mexico
About this study
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.
- Conditions
- Tobacco Abstinence Syndrome
- Being tested
- Intranasal Insulin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal InsulinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Insulin First | Active comparator | Intranasal Insulin First, Placebo Second Receives: Drug: Intranasal Insulin |
| Placebo First | Placebo comparator | Placebo First, Intranasal Insulin Second Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount Eaten in Taste Test
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
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 Abstinence SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajna Hamidovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ajna Hamidovic, University of New Mexico
- Investigators
- Ajna Hamidovic, PharmD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028871
- Sponsor's protocol ID
- 120700
- Status last verified
- Dec 2018
- First submitted
- 3 Jan 2014
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Insulin for Weight Management During Smoking Cessation
- ClinicalTrials.gov ID
- NCT02028871
- Acronym / sponsor ID
- 120700
- Conditions
- Tobacco Abstinence Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ajna HamidovicUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 10 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Insulin First | Active comparator | Drug: Intranasal InsulinIntranasal Insulin First, Placebo Second |
| Placebo First | Placebo comparator | Drug: PlaceboPlacebo First, Intranasal Insulin Second |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- smokers (>10 cig/day) for the past 1 year
- normosmic olfactory function
Key exclusion criteria (9 listed)
- previous/current use of insulin
- current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
- current pregnancy (or lactation)
- lifetime history of endocrine disease
- excessive alcohol use (>25 standard units of alcohol/week)
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 |
|---|---|---|
| Intranasal Insulin | Drug | Intranasal Insulin First |
| Placebo | Drug | Placebo First |
Primary outcome
Amount Eaten in Taste Test
Time frame: 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ajna Hamidovic, PharmD principal investigator
University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Insulin in people with Tobacco Abstinence Syndrome, run by Ajna Hamidovic at 2 sites 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 9 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 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2018). 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?
Amount Eaten in Taste Test (time frame: 90 minutes). 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 10 Dec 2018.