Trial Outcomes & Findings for Persistence-Targeted Smoking Cessation (NCT NCT01654107)
NCT ID: NCT01654107
Last Updated: 2017-08-21
Results Overview
3-months after the Quit Date
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
3-months
Results posted on
2017-08-21
Participant Flow
Participant milestones
| Measure |
Persistence Targeted Smoking Cessation
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
Clearing The Air
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Persistence-Targeted Smoking Cessation
Baseline characteristics by cohort
| Measure |
Persistence Targeted Smoking Cessation
n=28 Participants
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
Clearing The Air
n=30 Participants
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.82 years
STANDARD_DEVIATION 10.205 • n=5 Participants
|
48.93 years
STANDARD_DEVIATION 8.574 • n=7 Participants
|
48.40 years
STANDARD_DEVIATION 9.330 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-months3-months after the Quit Date
Outcome measures
| Measure |
Persistence Targeted Smoking Cessation
n=25 Participants
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
Clearing The Air
n=28 Participants
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
|---|---|---|
|
7-day Point Prevalence Abstinence
|
4 participants
|
1 participants
|
Adverse Events
Persistence Targeted Smoking Cessation
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Clearing The Air
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Persistence Targeted Smoking Cessation
n=28 participants at risk
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
Clearing The Air
n=30 participants at risk
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Nicotine lozenge: 12-weeks 4mg nicotine lozenge
|
|---|---|---|
|
General disorders
Dry Mouth
|
3.6%
1/28
|
6.7%
2/30
|
|
General disorders
Throat irritation
|
28.6%
8/28
|
13.3%
4/30
|
|
Gastrointestinal disorders
Upset stomach
|
10.7%
3/28
|
3.3%
1/30
|
|
Psychiatric disorders
Insomnia
|
14.3%
4/28
|
0.00%
0/30
|
|
Gastrointestinal disorders
Heartburn
|
7.1%
2/28
|
0.00%
0/30
|
|
General disorders
Hiccups
|
14.3%
4/28
|
0.00%
0/30
|
|
General disorders
Coughing
|
7.1%
2/28
|
3.3%
1/30
|
|
General disorders
Sore throat
|
7.1%
2/28
|
3.3%
1/30
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28
|
3.3%
1/30
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28
|
3.3%
1/30
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28
|
10.0%
3/30
|
|
Immune system disorders
Cold symptoms
|
3.6%
1/28
|
6.7%
2/30
|
|
Gastrointestinal disorders
Decreased appetite
|
3.6%
1/28
|
0.00%
0/30
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28
|
0.00%
0/30
|
|
Immune system disorders
Nasal congestion
|
3.6%
1/28
|
0.00%
0/30
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28
|
0.00%
0/30
|
|
Nervous system disorders
Migraine
|
3.6%
1/28
|
3.3%
1/30
|
|
General disorders
Tooth ache
|
3.6%
1/28
|
0.00%
0/30
|
|
Gastrointestinal disorders
Irregular Bowel Movement
|
3.6%
1/28
|
0.00%
0/30
|
|
Cardiac disorders
Heart flutter
|
3.6%
1/28
|
0.00%
0/30
|
|
Nervous system disorders
Headache
|
3.6%
1/28
|
3.3%
1/30
|
|
General disorders
Sweating
|
0.00%
0/28
|
3.3%
1/30
|
|
General disorders
Nose flaring
|
0.00%
0/28
|
3.3%
1/30
|
|
General disorders
Burning sensation in cheek area
|
0.00%
0/28
|
3.3%
1/30
|
|
General disorders
Sore gums
|
0.00%
0/28
|
3.3%
1/30
|
|
General disorders
Canker sore
|
0.00%
0/28
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/28
|
3.3%
1/30
|
|
Nervous system disorders
Fibromyalgia pain worsening
|
0.00%
0/28
|
3.3%
1/30
|
|
Psychiatric disorders
Irritability
|
0.00%
0/28
|
6.7%
2/30
|
|
Psychiatric disorders
Poor concentration/forgetfulness
|
0.00%
0/28
|
3.3%
1/30
|
|
Gastrointestinal disorders
Increased appetite
|
0.00%
0/28
|
3.3%
1/30
|
|
General disorders
Burning pepper taste
|
0.00%
0/28
|
3.3%
1/30
|
Additional Information
Marc L. Steinberg, Ph.D.
Rutgers Robert Wood Johnson Medical School
Phone: 7322354341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place