Tobacco Abstinence Syndrome
Conditions
Brief 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.
Interventions
DRUGIntranasal Insulin
DRUGPlacebo
Sponsors
Ajna Hamidovic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* smokers (\>10 cig/day) for the past 1 year * normosmic olfactory function
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount Eaten in Taste Test | 90 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Cravings Measured by Questionnaire of Smoking Urges | 210 minutes | Range: 7-70. Higher scores mean worse outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo first | 9 |
| Intranasal Insulin Arm Active treatment first | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Current Illness | 1 | 0 |
| Overall Study | IV placement difficulty | 1 | 0 |
| Overall Study | Positive urine drug screen | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Intranasal Insulin Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 38.33 years STANDARD_DEVIATION 12.82 | 29.30 years STANDARD_DEVIATION 7.14 | 33.57895 years STANDARD_DEVIATION 10.81198 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 10 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 13 Participants |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 19 |
| other Total, other adverse events | 11 / 26 | 7 / 24 | 5 / 19 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 0 / 19 |
Outcome results
Primary
Amount Eaten in Taste Test
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin Arm | Amount Eaten in Taste Test | 124 grams | Standard Deviation 48 |
| Placebo | Amount Eaten in Taste Test | 116 grams | Standard Deviation 66 |
Other Pre-specified
Nicotine Cravings Measured by Questionnaire of Smoking Urges
Range: 7-70. Higher scores mean worse outcome
Time frame: 210 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin Arm | Nicotine Cravings Measured by Questionnaire of Smoking Urges | 35.98 score on a scale | Standard Error 1.2 |
| Placebo | Nicotine Cravings Measured by Questionnaire of Smoking Urges | 32.52 score on a scale | Standard Error 1.05 |