Tobacco Use Disorder
Conditions
Keywords
tobacco, smoking cessation, nicotine dependence
Brief summary
The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).
Detailed description
In this Stage I Behavioral & Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.
Interventions
BEHAVIORALPersistence Targeted Smoking Cessation
8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)
BEHAVIORALClearing The Air
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
DRUGNicotine lozenge
12-weeks 4mg nicotine lozenge
Sponsors
National Institute on Drug Abuse (NIDA)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be between 18 - 64 years old * Must smoke at least 10 cigarettes per day for past 6-months * Expired breath carbon monoxide (CO) \> 7 * Must have a working cellular phone
Exclusion criteria
* Must not be currently receiving tobacco dependence treatment counseling * Must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler) * Must have no contraindications to using nicotine lozenge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Abstinence | 3-months | 3-months after the Quit Date |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| 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 | 30 |
| Total | 58 |
Baseline characteristics
| Characteristic | Persistence Targeted Smoking Cessation | Clearing The Air | Total |
|---|---|---|---|
| Age, Continuous | 47.82 years STANDARD_DEVIATION 10.205 | 48.93 years STANDARD_DEVIATION 8.574 | 48.40 years STANDARD_DEVIATION 9.33 |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 28 | 13 / 30 |
| serious Total, serious adverse events | 0 / 28 | 0 / 30 |
Outcome results
Primary
7-day Point Prevalence Abstinence
3-months after the Quit Date
Time frame: 3-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Persistence Targeted Smoking Cessation | 7-day Point Prevalence Abstinence | 4 participants |
| Clearing The Air | 7-day Point Prevalence Abstinence | 1 participants |