Trial Outcomes & Findings for Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation (NCT NCT02927847)
NCT ID: NCT02927847
Last Updated: 2022-06-28
Results Overview
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to monetary reward anticipation. BOLD signal change is estimated from the contrast of monetary reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
baseline, week 5
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
|
Overall Study
COMPLETED
|
10
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
PI withdrawn due to missed visits
|
1
|
1
|
Baseline Characteristics
Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation
Baseline characteristics by cohort
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
n=16 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
n=19 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 5Population: Participants without good fMRI data at baseline or week 5 (due to missed session, signal dropout, or artifacts) are not included in analyses.
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to monetary reward anticipation. BOLD signal change is estimated from the contrast of monetary reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
Outcome measures
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
n=10 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
n=14 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
|---|---|---|
|
Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward
|
-0.085 fMRI BOLD signal
Standard Deviation 0.21
|
-0.067 fMRI BOLD signal
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: baseline, week 5Population: Participants without good fMRI data at baseline or week 5 (due to missed session, signal dropout, or artifacts) are not included in analyses.
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking reward anticipation. BOLD signal change is estimated from the contrast of smoking reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
Outcome measures
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
n=10 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
n=14 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
|---|---|---|
|
Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward
|
0.011 fMRI BOLD signal
Standard Deviation 0.157
|
-0.036 fMRI BOLD signal
Standard Deviation 0.226
|
PRIMARY outcome
Timeframe: weeks 6 to 13Relapse is defined as return to 7 consecutive days of smoking.
Outcome measures
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
n=16 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
n=19 Participants
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
|---|---|---|
|
Number of Participants Who Relapsed or Are Presumed to Have Relapsed
|
9 Participants
|
9 Participants
|
Adverse Events
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
VLNC (Very Low Nicotine Cigarettes) Only
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BA (Behavioral Activation) + VLNC (Very Low Nicotine Cigarettes)
n=16 participants at risk
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Behavioral Activation: Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
|
VLNC (Very Low Nicotine Cigarettes) Only
n=19 participants at risk
Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
Nicotine Patch: Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
SPECTRUM Nicotine Research Cigarettes (.03 mg): For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Supportive Counseling: Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itchiness at patch site
|
25.0%
4/16 • Week 1 to week 13
|
26.3%
5/19 • Week 1 to week 13
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Week 1 to week 13
|
10.5%
2/19 • Week 1 to week 13
|
|
Respiratory, thoracic and mediastinal disorders
Cold/upper respiratory infection
|
25.0%
4/16 • Week 1 to week 13
|
21.1%
4/19 • Week 1 to week 13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Week 1 to week 13
|
26.3%
5/19 • Week 1 to week 13
|
|
Infections and infestations
Fever
|
0.00%
0/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose/congestion
|
6.2%
1/16 • Week 1 to week 13
|
10.5%
2/19 • Week 1 to week 13
|
|
Respiratory, thoracic and mediastinal disorders
Increased phlegm
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Respiratory, thoracic and mediastinal disorders
Loss of voice
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Respiratory, thoracic and mediastinal disorders
Mouth/throat irritaiton
|
12.5%
2/16 • Week 1 to week 13
|
26.3%
5/19 • Week 1 to week 13
|
|
Gastrointestinal disorders
Heart burn
|
12.5%
2/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Gastrointestinal disorders
Hunger
|
0.00%
0/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Gastrointestinal disorders
Stomach bug
|
18.8%
3/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Gastrointestinal disorders
Upset stomach/nausea
|
6.2%
1/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Week 1 to week 13
|
15.8%
3/19 • Week 1 to week 13
|
|
Nervous system disorders
Phantom Limb
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Nervous system disorders
Heat sensitivity in extremeties
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Musculoskeletal and connective tissue disorders
Tightness in lower back
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Musculoskeletal and connective tissue disorders
Arthritis/joint pain
|
0.00%
0/16 • Week 1 to week 13
|
10.5%
2/19 • Week 1 to week 13
|
|
Social circumstances
Stress
|
12.5%
2/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
General disorders
Vivid or abnormal dreams
|
31.2%
5/16 • Week 1 to week 13
|
26.3%
5/19 • Week 1 to week 13
|
|
General disorders
Insomnia
|
12.5%
2/16 • Week 1 to week 13
|
15.8%
3/19 • Week 1 to week 13
|
|
General disorders
Sleep issues
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
General disorders
Sedation
|
0.00%
0/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
General disorders
Nicotine withdrawal
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Psychiatric disorders
Irritability
|
37.5%
6/16 • Week 1 to week 13
|
26.3%
5/19 • Week 1 to week 13
|
|
Psychiatric disorders
Jitteriness
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Psychiatric disorders
Sadness
|
0.00%
0/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/16 • Week 1 to week 13
|
5.3%
1/19 • Week 1 to week 13
|
|
Immune system disorders
Allergies/hay fever
|
6.2%
1/16 • Week 1 to week 13
|
10.5%
2/19 • Week 1 to week 13
|
|
Immune system disorders
Food allergy
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Injury, poisoning and procedural complications
Car accident
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Injury, poisoning and procedural complications
Cut finger/hand
|
0.00%
0/16 • Week 1 to week 13
|
10.5%
2/19 • Week 1 to week 13
|
|
Injury, poisoning and procedural complications
Poison ivy
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
|
Surgical and medical procedures
Root canal
|
6.2%
1/16 • Week 1 to week 13
|
0.00%
0/19 • Week 1 to week 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place