Exenatide Once Weekly for Smoking Cessation
Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT02975297
Collaborator
(none)
84
1
2
42.1
2
Study Details
Study Description
Brief Summary
The purpose of this study is to identify a potential new treatment for smoking cessation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial
Actual Study Start Date
:
Jul 1, 2016
Actual Primary Completion Date
:
Jan 3, 2020
Actual Study Completion Date
:
Jan 3, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exenatide plus NRT plus counseling Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling |
Drug: Exenatide
Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
Other Names:
Drug: NRT
Nicotine Patch (21mg) / 24 hours.
Other Names:
Behavioral: Counseling
Brief individual behavioral smoking cessation counseling.
Other Names:
|
| Placebo Comparator: Placebo plus NRT plus counseling Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling |
Drug: NRT
Nicotine Patch (21mg) / 24 hours.
Other Names:
Behavioral: Counseling
Brief individual behavioral smoking cessation counseling.
Other Names:
Drug: Placebo
Normal saline.
|
Outcome Measures
Primary Outcome Measures
- 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.
- Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges [3 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.
Secondary Outcome Measures
- 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)]
- Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm [10 weeks (4 weeks 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.
- Post-quit Craving as Assessed by the Questionnaire of Smoking Urges [10 weeks (4 weeks 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Luba Yammine, PhD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Luba Yammine,
Associate Professor,
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02975297
Other Study ID Numbers:
- HSC-MS-17-0802
- CCTS Research Scholar Award
First Posted:
Nov 29, 2016
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Luba Yammine,
Associate Professor,
The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 1 participant in the exenatide arm did not receive exenatide, and 1 participant in the placebo arm did not receive placebo. |
| Arm/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 41 | 41 |
| COMPLETED | 34 | 35 |
| NOT COMPLETED | 7 | 6 |
Baseline Characteristics
| Arm/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 41 | 41 | 82 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.0
(9.1)
|
51.2
(9.4)
|
51.1
(9.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
13
31.7%
|
12
29.3%
|
25
30.5%
|
| Male |
28
68.3%
|
29
70.7%
|
57
69.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Black/African American |
25
61%
|
27
65.9%
|
52
63.4%
|
| White |
14
34.1%
|
13
31.7%
|
27
32.9%
|
| Hispanic/Latino |
0
0%
|
1
2.4%
|
1
1.2%
|
| Other |
2
4.9%
|
0
0%
|
2
2.4%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
41
100%
|
41
100%
|
82
100%
|
| Marital Status (Count of Participants) | |||
| Never Married |
17
41.5%
|
14
34.1%
|
31
37.8%
|
| Divorced/Separated |
17
41.5%
|
20
48.8%
|
37
45.1%
|
| Married |
6
14.6%
|
4
9.8%
|
10
12.2%
|
| Widowed |
1
2.4%
|
3
7.3%
|
4
4.9%
|
| Highest Level of Education (Count of Participants) | |||
| 8th Grade or Less |
1
2.4%
|
2
4.9%
|
3
3.7%
|
| High School |
27
65.9%
|
24
58.5%
|
51
62.2%
|
| College Degree |
11
26.8%
|
12
29.3%
|
23
28%
|
| Graduate Degree |
2
4.9%
|
3
7.3%
|
5
6.1%
|
| Household Income (Count of Participants) | |||
| <$19,999 |
23
56.1%
|
26
63.4%
|
49
59.8%
|
| $20,000-39,999 |
12
29.3%
|
10
24.4%
|
22
26.8%
|
| $40,000-59,999 |
2
4.9%
|
2
4.9%
|
4
4.9%
|
| $60,000-79,999 |
4
9.8%
|
0
0%
|
4
4.9%
|
| $80,000-99,999 |
0
0%
|
1
2.4%
|
1
1.2%
|
| >$100,000 |
0
0%
|
1
2.4%
|
1
1.2%
|
| Not reported |
0
0%
|
1
2.4%
|
1
1.2%
|
| Cigarettes Smoked per Day (Cigarettes Smoked per Day) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Cigarettes Smoked per Day] |
18.5
(8.7)
|
18.4
(9.3)
|
18.4
(8.9)
|
| Years of Regular Smoking (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
27.4
(11)
|
26.6
(12.7)
|
27.0
(11.8)
|
| Nicotine Dependence as Assessed by the Fagerstrom Test for Nicotine Dependence (FTND) (score on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [score on a scale] |
6.3
(1.9)
|
6
(2.5)
|
6.2
(2.2)
|
| Positive Affect as Assessed by the Positive and Negative Affect Schedule (PANAS) (score on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [score on a scale] |
35.9
(10.1)
|
32.5
(9.8)
|
34.2
(10)
|
| Negative Affect as Assessed by the Positive and Negative Affect Schedule (PANAS) (score on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [score on a scale] |
18.6
(7.6)
|
20.1
(8.0)
|
19.3
(7.8)
|
| Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-8) (score on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [score on a scale] |
8.3
(6.4)
|
8.6
(5.9)
|
8.5
(6.1)
|
Outcome Measures
| Title | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm |
|---|---|
| Description | |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 41 | 41 |
| Count of Participants [Participants] |
19
46.3%
|
11
26.8%
|
| Title | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 34 | 35 |
| Mean (Standard Deviation) [score on a scale] |
17.2
(11.0)
|
16.9
(9.75)
|
| Title | Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 34 | 35 |
| Mean (Standard Deviation) [score on a scale] |
40.5
(18.3)
|
44.5
(18.0)
|
| Title | Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 0 | 0 |
| Title | Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 0 | 0 |
| Title | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm |
|---|---|
| Description | |
| Time Frame | 7 weeks (1 week after end of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 19 | 11 |
| Count of Participants [Participants] |
15
36.6%
|
7
17.1%
|
| Title | Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm |
|---|---|
| Description | |
| Time Frame | 10 weeks (4 weeks after end of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 19 | 11 |
| Count of Participants [Participants] |
9
22%
|
4
9.8%
|
| Title | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 16 | 9 |
| Mean (Standard Deviation) [score on a scale] |
13.3
(7.86)
|
14.2
(8.47)
|
| Title | Post-quit Craving as Assessed by the Questionnaire of Smoking Urges |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 11 | 4 |
| Mean (Standard Deviation) [score on a scale] |
11.5
(5.13)
|
11.2
(2.5)
|
Adverse Events
| Time Frame | 10 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 0/41 (0%) | ||
Serious Adverse Events |
||||
| Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | 0/41 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Exenatide Plus NRT Plus Counseling | Placebo Plus NRT Plus Counseling | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/41 (9.8%) | 1/41 (2.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Injection site nodule | 4/41 (9.8%) | 4 | 0/41 (0%) | 0 |
| Pruritus at the site of nicotine patch application | 0/41 (0%) | 0 | 1/41 (2.4%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Luba Yammine, PhD, APRN, FNP-C, Associate Professor |
|---|---|
| Organization | The University of Texas Health Science Center at Houston |
| Phone | (713) 500-2005 |
| Luba.Yammine@uth.tmc.edu |
Responsible Party:
Luba Yammine,
Associate Professor,
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02975297
Other Study ID Numbers:
- HSC-MS-17-0802
- CCTS Research Scholar Award
First Posted:
Nov 29, 2016
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021