Trial Outcomes & Findings for Behavioral Activation for Smoking Cessation in PTSD (NCT NCT01995123)
NCT ID: NCT01995123
Last Updated: 2020-04-15
Results Overview
7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
26 weeks post target quit date
Results posted on
2020-04-15
Participant Flow
Participant milestones
| Measure |
Behavioral Activation Therapy
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
61
|
|
Overall Study
COMPLETED
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing age data from three participants.
Baseline characteristics by cohort
| Measure |
Behavioral Activation Therapy
n=63 Participants
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
n=61 Participants
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=61 Participants • Missing age data from three participants.
|
0 Participants
n=60 Participants • Missing age data from three participants.
|
0 Participants
n=121 Participants • Missing age data from three participants.
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=61 Participants • Missing age data from three participants.
|
54 Participants
n=60 Participants • Missing age data from three participants.
|
109 Participants
n=121 Participants • Missing age data from three participants.
|
|
Age, Categorical
>=65 years
|
6 Participants
n=61 Participants • Missing age data from three participants.
|
6 Participants
n=60 Participants • Missing age data from three participants.
|
12 Participants
n=121 Participants • Missing age data from three participants.
|
|
Age, Continuous
|
50.70 years
STANDARD_DEVIATION 12.01 • n=61 Participants • Missing age data from three participants.
|
47.17 years
STANDARD_DEVIATION 13.02 • n=60 Participants • Missing age data from three participants.
|
48.95 years
STANDARD_DEVIATION 12.59 • n=121 Participants • Missing age data from three participants.
|
|
Sex: Female, Male
Female
|
11 Participants
n=63 Participants
|
4 Participants
n=61 Participants
|
15 Participants
n=124 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=63 Participants
|
57 Participants
n=61 Participants
|
109 Participants
n=124 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=63 Participants
|
2 Participants
n=61 Participants
|
4 Participants
n=124 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=63 Participants
|
59 Participants
n=61 Participants
|
120 Participants
n=124 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=63 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=124 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=63 Participants
|
1 Participants
n=61 Participants
|
2 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=63 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=63 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=63 Participants
|
7 Participants
n=61 Participants
|
11 Participants
n=124 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=63 Participants
|
52 Participants
n=61 Participants
|
106 Participants
n=124 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=63 Participants
|
1 Participants
n=61 Participants
|
3 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=63 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=124 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=63 Participants
|
61 Participants
n=61 Participants
|
124 Participants
n=124 Participants
|
|
Baseline cigarettes smoked per day
|
18.67 Cigarettes per day
STANDARD_DEVIATION 7.26 • n=63 Participants
|
17.34 Cigarettes per day
STANDARD_DEVIATION 8.26 • n=61 Participants
|
17.99 Cigarettes per day
STANDARD_DEVIATION 7.78 • n=124 Participants
|
PRIMARY outcome
Timeframe: 26 weeks post target quit date7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day
Outcome measures
| Measure |
Behavioral Activation Therapy
n=63 Participants
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
n=61 Participants
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
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|---|---|---|
|
Percentage of Participants Who Abstained From Smoking
Week 4
|
23 Participants
|
21 Participants
|
|
Percentage of Participants Who Abstained From Smoking
Week 12
|
20 Participants
|
19 Participants
|
|
Percentage of Participants Who Abstained From Smoking
Week 20
|
22 Participants
|
14 Participants
|
|
Percentage of Participants Who Abstained From Smoking
Week 26
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 26 weeks post target quit dateDays to first relapse after the target quit date
Outcome measures
| Measure |
Behavioral Activation Therapy
n=63 Participants
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
n=61 Participants
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
|---|---|---|
|
Time to Smoking Relapse
|
88.41 Days
Standard Deviation 73.46
|
84.34 Days
Standard Deviation 72.29
|
SECONDARY outcome
Timeframe: 4 weeks post target quit date (end of treatment)Population: Outcome Measure assessed at separate study visit. Data reported for participants who were assessed at this visit.
PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.
Outcome measures
| Measure |
Behavioral Activation Therapy
n=46 Participants
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
n=45 Participants
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
|---|---|---|
|
Clinician Administered PTSD Scale Score
|
30.78 Units on a scale
Standard Deviation 11.80
|
27.33 Units on a scale
Standard Deviation 13.29
|
Adverse Events
Behavioral Activation Therapy
Serious events: 7 serious events
Other events: 33 other events
Deaths: 1 deaths
Health and Smoking Education
Serious events: 6 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Behavioral Activation Therapy
n=63 participants at risk
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
n=61 participants at risk
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
|---|---|---|
|
Cardiac disorders
Hospitalized for chest pain
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
0.00%
0/61 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
General disorders
Hospitalized for fall
|
0.00%
0/63 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Psychiatric disorders
Hospitalized for suicidal ideation
|
0.00%
0/63 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
3.3%
2/61 • Number of events 2 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for shortness of breath
|
3.2%
2/63 • Number of events 3 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
0.00%
0/61 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Nervous system disorders
Hospitalized for lightheadedness
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
0.00%
0/61 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Nervous system disorders
Hospitalized for TIA
|
0.00%
0/63 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Surgical and medical procedures
Hospitalized for wound care
|
0.00%
0/63 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for pneumonia
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
0.00%
0/61 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Musculoskeletal and connective tissue disorders
Hospitalized for back pain
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
0.00%
0/61 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
General disorders
Death
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
Other adverse events
| Measure |
Behavioral Activation Therapy
n=63 participants at risk
Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Behavioral Activation Therapy: Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
Health and Smoking Education
n=61 participants at risk
Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health. In addition, this arm will receive standard smoking cessation therapy, nicotine patch, and either nicotine gum or nicotine lozenge.
Health and Smoking Education: Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
Standard Smoking Cessation Therapy: Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.8%
3/63 • Number of events 3 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
6.6%
4/61 • Number of events 4 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/63 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
6.6%
4/61 • Number of events 4 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Nervous system disorders
Headache
|
7.9%
5/63 • Number of events 7 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
13.1%
8/61 • Number of events 11 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Skin and subcutaneous tissue disorders
Itching
|
15.9%
10/63 • Number of events 10 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
18.0%
11/61 • Number of events 11 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Skin and subcutaneous tissue disorders
Swelling or tingling of the mouth
|
6.3%
4/63 • Number of events 4 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
1.6%
1/61 • Number of events 3 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
11.1%
7/63 • Number of events 8 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
3.3%
2/61 • Number of events 4 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Psychiatric disorders
Insomnia
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
8.2%
5/61 • Number of events 10 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Psychiatric disorders
Vivid dreams
|
15.9%
10/63 • Number of events 13 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
6.6%
4/61 • Number of events 10 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Gastrointestinal disorders
Hiccups
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
3.3%
2/61 • Number of events 2 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Skin and subcutaneous tissue disorders
Mouth problems
|
3.2%
2/63 • Number of events 4 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
|
Gastrointestinal disorders
Persistent indigestion
|
12.7%
8/63 • Number of events 9 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
9.8%
6/61 • Number of events 7 • Adverse event data were collected for 12 weeks post-target quit date while participants were taking study medication (nicotine patch and nicotine gum or lozenge).
Study participants were asked: "Since our last contact, have there been any changes in your medical condition or health?" on the quit day, at weeks 1 through 4 post-quit, and at the 3-month follow up call. Participants also could self-initiate symptom reports during other phone calls.
|
Additional Information
Jessica Cook, PhD
Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health; William S Middleton Memorial Veterans Hospital
Phone: 608-265-9775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place