Tobacco Abstinence Syndrome
Conditions
Brief summary
This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.
Interventions
DRUGIntranasal Insulin
DRUGPlacebo
Sponsors
Ajna Hamidovic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 | Description |
|---|---|---|
| Episodic Memory | 90 minutes | California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome |
| Salivary Cortisol | 90 minutes | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Craving (Measured by Questionnaire of Smoking Urges) | 90 minutes | Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Insulin Group receiving active treatment | 16 |
| Placebo Group receiving placebo | 21 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Intranasal Insulin | Placebo | 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 | 16 Participants | 21 Participants | 37 Participants |
| Age, Continuous | 35.75 years STANDARD_DEVIATION 13.23 | 40.19 years STANDARD_DEVIATION 13.74 | 37.34694 years STANDARD_DEVIATION 12.45417 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 27 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 | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 19 Participants |
| Race (NIH/OMB) White | 9 Participants | 6 Participants | 15 Participants |
| Region of Enrollment United States | 16 participants | 21 participants | 37 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 24 |
| other Total, other adverse events | 25 / 27 | 13 / 24 |
| serious Total, serious adverse events | 0 / 27 | 0 / 24 |
Outcome results
Primary
Episodic Memory
California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin | Episodic Memory | 11.6 number of words recalled | Standard Error 0.3 |
| Placebo | Episodic Memory | 10.0 number of words recalled | Standard Error 0.3 |
Primary
Salivary Cortisol
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin | Salivary Cortisol | 0.23 mcg/dL | Standard Error 0.02 |
| Placebo | Salivary Cortisol | 0.13 mcg/dL | Standard Error 0.01 |
Other Pre-specified
Nicotine Craving (Measured by Questionnaire of Smoking Urges)
Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin | Nicotine Craving (Measured by Questionnaire of Smoking Urges) | 30.48 units on a scale | Standard Error 1.42 |
| Placebo | Nicotine Craving (Measured by Questionnaire of Smoking Urges) | 43.44 units on a scale | Standard Error 1.39 |