Trial Outcomes & Findings for Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders (NCT NCT02232737)
NCT ID: NCT02232737
Last Updated: 2022-12-07
Results Overview
Participant reported number of cigarettes smoked per day at Week 12
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
775 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-12-07
Participant Flow
Participant milestones
| Measure |
0.8 mg Nicotine
0.8 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.12 mg Nicotine
0.12 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.03 mg Nicotine
0.03 mg nicotine cigarettes
Very low nicotine content cigarettes
|
|---|---|---|---|
|
Overall Study
STARTED
|
254
|
235
|
286
|
|
Overall Study
COMPLETED
|
218
|
190
|
224
|
|
Overall Study
NOT COMPLETED
|
36
|
45
|
62
|
Reasons for withdrawal
| Measure |
0.8 mg Nicotine
0.8 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.12 mg Nicotine
0.12 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.03 mg Nicotine
0.03 mg nicotine cigarettes
Very low nicotine content cigarettes
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
18
|
28
|
33
|
|
Overall Study
Personal reasons
|
7
|
8
|
14
|
|
Overall Study
Adverse Event
|
6
|
3
|
8
|
|
Overall Study
Incarcerated
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Reason unknown
|
1
|
0
|
0
|
Baseline Characteristics
Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
Baseline characteristics by cohort
| Measure |
0.8 mg Nicotine
n=254 Participants
0.8 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.12 mg Nicotine
n=235 Participants
0.12 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.03 mg Nicotine
n=286 Participants
0.03 mg nicotine cigarettes
Very low nicotine content cigarettes
|
Total
n=775 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.90 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
35.18 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
35.65 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
35.59 years
STANDARD_DEVIATION 11.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
551 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Latino White
|
207 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
630 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Latino Black
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Latino Other
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
254 participants
n=5 Participants
|
235 participants
n=7 Participants
|
286 participants
n=5 Participants
|
775 participants
n=4 Participants
|
|
Cigarettes Per Day
|
19.63 Cigarettes Per Day
STANDARD_DEVIATION 10.33 • n=5 Participants
|
19.54 Cigarettes Per Day
STANDARD_DEVIATION 10.56 • n=7 Participants
|
19.91 Cigarettes Per Day
STANDARD_DEVIATION 10.84 • n=5 Participants
|
19.71 Cigarettes Per Day
STANDARD_DEVIATION 10.58 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who completed Week 12
Participant reported number of cigarettes smoked per day at Week 12
Outcome measures
| Measure |
0.8 mg Nicotine
n=218 Participants
0.8 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.12 mg Nicotine
n=190 Participants
0.12 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.03 mg Nicotine
n=224 Participants
0.03 mg nicotine cigarettes
Very low nicotine content cigarettes
|
|---|---|---|---|
|
Cigarettes Per Day (CPD)
|
25.28 cigarettes per day
Standard Error 0.77
|
19.95 cigarettes per day
Standard Error 0.80
|
17.74 cigarettes per day
Standard Error 0.74
|
Adverse Events
0.8 mg Nicotine
Serious events: 13 serious events
Other events: 241 other events
Deaths: 0 deaths
0.12 mg Nicotine
Serious events: 4 serious events
Other events: 203 other events
Deaths: 1 deaths
0.03 mg Nicotine
Serious events: 13 serious events
Other events: 226 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
0.8 mg Nicotine
n=254 participants at risk
0.8 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.12 mg Nicotine
n=235 participants at risk
0.12 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.03 mg Nicotine
n=286 participants at risk
0.03 mg nicotine cigarettes
Very low nicotine content cigarettes
|
|---|---|---|---|
|
Cardiac disorders
Sudden onset of chest pain due to not enough blood going to the heart
|
0.79%
2/254 • Number of events 2 • 12 weeks
|
0.43%
1/235 • Number of events 1 • 12 weeks
|
0.00%
0/286 • 12 weeks
|
|
Eye disorders
Blurred vision
|
0.39%
1/254 • Number of events 1 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.00%
0/286 • 12 weeks
|
|
Gastrointestinal disorders
Bloody stool
|
0.00%
0/254 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.35%
1/286 • Number of events 4 • 12 weeks
|
|
Infections and infestations
Kidney infection
|
1.2%
3/254 • Number of events 4 • 12 weeks
|
0.43%
1/235 • Number of events 1 • 12 weeks
|
0.35%
1/286 • Number of events 2 • 12 weeks
|
|
Injury, poisoning and procedural complications
Broken bone
|
0.00%
0/254 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.70%
2/286 • Number of events 7 • 12 weeks
|
|
Investigations
Frontal lobe lesion
|
0.00%
0/254 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.35%
1/286 • Number of events 2 • 12 weeks
|
|
Metabolism and nutrition disorders
Diabetes Type 2
|
0.39%
1/254 • Number of events 1 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.35%
1/286 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis of the Hand
|
0.39%
1/254 • Number of events 1 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.00%
0/286 • 12 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/254 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
1.0%
3/286 • Number of events 5 • 12 weeks
|
|
Psychiatric disorders
Anxiety, feelings of dread or danger
|
0.79%
2/254 • Number of events 2 • 12 weeks
|
0.43%
1/235 • Number of events 1 • 12 weeks
|
0.70%
2/286 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
Acute renal failure
|
0.39%
1/254 • Number of events 1 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.00%
0/286 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin graft to wound on leg
|
0.00%
0/254 • 12 weeks
|
0.43%
1/235 • Number of events 1 • 12 weeks
|
0.00%
0/286 • 12 weeks
|
|
Surgical and medical procedures
Neurosurgery
|
0.39%
1/254 • Number of events 1 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.35%
1/286 • Number of events 1 • 12 weeks
|
|
Vascular disorders
High blood pressure
|
0.39%
1/254 • Number of events 1 • 12 weeks
|
0.00%
0/235 • 12 weeks
|
0.35%
1/286 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
0.8 mg Nicotine
n=254 participants at risk
0.8 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.12 mg Nicotine
n=235 participants at risk
0.12 mg nicotine cigarettes
Very low nicotine content cigarettes
|
0.03 mg Nicotine
n=286 participants at risk
0.03 mg nicotine cigarettes
Very low nicotine content cigarettes
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
24.8%
63/254 • Number of events 92 • 12 weeks
|
20.9%
49/235 • Number of events 71 • 12 weeks
|
26.9%
77/286 • Number of events 114 • 12 weeks
|
|
General disorders
General disorders
|
22.8%
58/254 • Number of events 77 • 12 weeks
|
19.6%
46/235 • Number of events 72 • 12 weeks
|
23.4%
67/286 • Number of events 85 • 12 weeks
|
|
Infections and infestations
Infections and infestations
|
35.0%
89/254 • Number of events 113 • 12 weeks
|
33.6%
79/235 • Number of events 106 • 12 weeks
|
32.2%
92/286 • Number of events 119 • 12 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications
|
8.7%
22/254 • Number of events 28 • 12 weeks
|
5.5%
13/235 • Number of events 13 • 12 weeks
|
5.9%
17/286 • Number of events 23 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
16.5%
42/254 • Number of events 52 • 12 weeks
|
11.5%
27/235 • Number of events 34 • 12 weeks
|
11.5%
33/286 • Number of events 41 • 12 weeks
|
|
Nervous system disorders
Nervous system disorders
|
19.3%
49/254 • Number of events 56 • 12 weeks
|
16.2%
38/235 • Number of events 52 • 12 weeks
|
16.1%
46/286 • Number of events 65 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
30.7%
78/254 • Number of events 112 • 12 weeks
|
30.6%
72/235 • Number of events 111 • 12 weeks
|
29.4%
84/286 • Number of events 114 • 12 weeks
|
|
Surgical and medical procedures
Surgical and medical procedures
|
9.1%
23/254 • Number of events 28 • 12 weeks
|
6.8%
16/235 • Number of events 25 • 12 weeks
|
9.1%
26/286 • Number of events 31 • 12 weeks
|
|
Vascular disorders
Vascular disorders
|
7.9%
20/254 • Number of events 30 • 12 weeks
|
9.4%
22/235 • Number of events 31 • 12 weeks
|
8.7%
25/286 • Number of events 34 • 12 weeks
|
Additional Information
Stephen T. Higgins, PhD, Professor
University of Vermont
Phone: 802-735-6267
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place