Smoking Cessation
Conditions
Keywords
smoking, pre-diabetes, overweight, exenatide, Glucagon-like peptide-1 (GLP-1) agonists
Brief summary
The purpose of this study is to identify a potential new treatment for smoking cessation.
Interventions
DRUGExenatide
Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
DRUGNRT
Nicotine Patch (21mg) / 24 hours.
BEHAVIORALCounseling
Brief individual behavioral smoking cessation counseling.
DRUGPlacebo
Normal saline.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study; * Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm; * Have a negative pregnancy test, if female of childbearing potential; * Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters * Not currently using any therapy for glycemic control (either injectable \[i.e. insulin\] or oral agents); * Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic; * Have hematology and chemistry laboratory tests that are within reference limits (within 10% above or below), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits; * Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the principal investigator.
Exclusion criteria
* Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features). * Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician. * Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI. * Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; * Have type 1 diabetes mellitus; * Have severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris); * Have active temporomandibular joint disease; * Have severe gastrointestinal disease (i.e. severe gastroparesis); * Have previous history of pancreatitis or are at risk for pancreatitis; * Have creatinine clearance (CrCl) \< 30; * Have any previous medically adverse reaction to study medications, nicotine, or menthol; * Be pregnant or lactating or unwilling to provide a negative pregnancy test before study entry; * Not using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide); * Have any illness which in the opinion of the primary investigator would preclude safe and/or successful completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 6 weeks | — |
| Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 6 weeks | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. |
| Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale | 6 weeks | The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal. |
| Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges | 1 week | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 7 weeks (1 week after end of treatment) | — |
| Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 7 weeks (1 week after end of treatment) | Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect. |
Countries
United States
Participant flow
Pre-assignment details
1 participant in the exenatide arm did not receive exenatide, and 1 participant in the placebo arm did not receive placebo.
Participants by arm
| Arm | Count |
|---|---|
| Exenatide Plus NRT Plus Counseling Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
Exenatide: Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling. | 41 |
| Placebo Plus NRT Plus Counseling Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
NRT: Nicotine Patch (21mg) / 24 hours.
Counseling: Brief individual behavioral smoking cessation counseling.
Placebo: Normal saline. | 41 |
| Total | 82 |
Baseline characteristics
| Characteristic | Placebo Plus NRT Plus Counseling | Total | Exenatide Plus NRT Plus Counseling |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 9.4 | 51.1 years STANDARD_DEVIATION 9.2 | 51.0 years STANDARD_DEVIATION 9.1 |
| Cigarettes Smoked per Day | 18.4 Cigarettes Smoked per Day STANDARD_DEVIATION 9.3 | 18.4 Cigarettes Smoked per Day STANDARD_DEVIATION 8.9 | 18.5 Cigarettes Smoked per Day STANDARD_DEVIATION 8.7 |
| Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-8) | 8.6 score on a scale STANDARD_DEVIATION 5.9 | 8.5 score on a scale STANDARD_DEVIATION 6.1 | 8.3 score on a scale STANDARD_DEVIATION 6.4 |
| Highest Level of Education 8th Grade or Less | 2 Participants | 3 Participants | 1 Participants |
| Highest Level of Education College Degree | 12 Participants | 23 Participants | 11 Participants |
| Highest Level of Education Graduate Degree | 3 Participants | 5 Participants | 2 Participants |
| Highest Level of Education High School | 24 Participants | 51 Participants | 27 Participants |
| Household Income >$100,000 | 1 Participants | 1 Participants | 0 Participants |
| Household Income <$19,999 | 26 Participants | 49 Participants | 23 Participants |
| Household Income $20,000-39,999 | 10 Participants | 22 Participants | 12 Participants |
| Household Income $40,000-59,999 | 2 Participants | 4 Participants | 2 Participants |
| Household Income $60,000-79,999 | 0 Participants | 4 Participants | 4 Participants |
| Household Income $80,000-99,999 | 1 Participants | 1 Participants | 0 Participants |
| Household Income Not reported | 1 Participants | 1 Participants | 0 Participants |
| Marital Status Divorced/Separated | 20 Participants | 37 Participants | 17 Participants |
| Marital Status Married | 4 Participants | 10 Participants | 6 Participants |
| Marital Status Never Married | 14 Participants | 31 Participants | 17 Participants |
| Marital Status Widowed | 3 Participants | 4 Participants | 1 Participants |
| Negative Affect as Assessed by the Positive and Negative Affect Schedule (PANAS) | 20.1 score on a scale STANDARD_DEVIATION 8 | 19.3 score on a scale STANDARD_DEVIATION 7.8 | 18.6 score on a scale STANDARD_DEVIATION 7.6 |
| Nicotine Dependence as Assessed by the Fagerstrom Test for Nicotine Dependence (FTND) | 6 score on a scale STANDARD_DEVIATION 2.5 | 6.2 score on a scale STANDARD_DEVIATION 2.2 | 6.3 score on a scale STANDARD_DEVIATION 1.9 |
| Positive Affect as Assessed by the Positive and Negative Affect Schedule (PANAS) | 32.5 score on a scale STANDARD_DEVIATION 9.8 | 34.2 score on a scale STANDARD_DEVIATION 10 | 35.9 score on a scale STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Black/African American | 27 Participants | 52 Participants | 25 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 27 Participants | 14 Participants |
| Region of Enrollment United States | 41 Participants | 82 Participants | 41 Participants |
| Sex: Female, Male Female | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Male | 29 Participants | 57 Participants | 28 Participants |
| Years of Regular Smoking | 26.6 years STANDARD_DEVIATION 12.7 | 27.0 years STANDARD_DEVIATION 11.8 | 27.4 years STANDARD_DEVIATION 11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 4 / 41 | 1 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
Primary
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Time frame: 1 week
Population: Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected.
Primary
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Time frame: 3 weeks
Population: Virtual reality exposure was not done due to transfer of the study to a different site; therefore, data for this outcome measure were not collected.
Primary
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide Plus NRT Plus Counseling | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 19 Participants |
| Placebo Plus NRT Plus Counseling | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 11 Participants |
Primary
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Time frame: 6 weeks
Population: Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Plus NRT Plus Counseling | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 17.2 score on a scale | Standard Deviation 11 |
| Placebo Plus NRT Plus Counseling | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 16.9 score on a scale | Standard Deviation 9.75 |
Primary
Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale
The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal.
Time frame: 6 weeks
Population: Data were not collected for 7 participants in the Exenatide plus NRT plus counseling arm and 6 participants in the Placebo plus NRT plus counseling arm. Overall Number of Participants Analyzed reflects participants who completed the study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Plus NRT Plus Counseling | Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale | 40.5 score on a scale | Standard Deviation 18.3 |
| Placebo Plus NRT Plus Counseling | Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale | 44.5 score on a scale | Standard Deviation 18 |
Secondary
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Time frame: 7 weeks (1 week after end of treatment)
Population: Data were not collected for 22 participants in the Exenatide plus NRT plus counseling arm and 30 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects the number of participants who were abstinent \[self-reported and verified by expired carbon monoxide (CO) levels (CO≤5 ppm)\] at 6 weeks (end of treatment).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide Plus NRT Plus Counseling | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 15 Participants |
| Placebo Plus NRT Plus Counseling | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 7 Participants |
Secondary
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
Time frame: 10 weeks (4 weeks after end of treatment)
Population: Data were not collected for 22 participants in the Exenatide plus NRT plus counseling arm and 30 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects the number of participants who were abstinent \[self-reported and verified by expired carbon monoxide (CO) levels (CO≤5 ppm)\] at 6 weeks (end of treatment).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exenatide Plus NRT Plus Counseling | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 9 Participants |
| Placebo Plus NRT Plus Counseling | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm | 4 Participants |
Secondary
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Time frame: 7 weeks (1 week after end of treatment)
Population: Data were not collected for 25 participants in the Exenatide plus NRT plus counseling arm and 32 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects those who completed the study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Plus NRT Plus Counseling | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 13.3 score on a scale | Standard Deviation 7.86 |
| Placebo Plus NRT Plus Counseling | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 14.2 score on a scale | Standard Deviation 8.47 |
Secondary
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Time frame: 10 weeks (4 weeks after end of treatment)
Population: Data were not collected for 30 participants in the Exenatide plus NRT plus counseling arm and 37 participants in the Placebo plus NRT plus counseling arm. The Overall Number of Participants Analyzed reflects those who completed the study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Plus NRT Plus Counseling | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 11.5 score on a scale | Standard Deviation 5.13 |
| Placebo Plus NRT Plus Counseling | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges | 11.2 score on a scale | Standard Deviation 2.5 |