Smoking, Smoking Cessation
Conditions
Keywords
smoking, smoking cessation, nicotine replacement therapy, primary care, comparative effectiveness
Brief summary
The purpose of this study is to evaluate the use of sampling of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.
Interventions
2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
BEHAVIORALAsk, Advise, Refer (physician brief advice)
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>=18 * daily (25+ days within past 30) cigarette smoker of \>5 cigs/day * English speaking * recruited through primary care sites aligned with study
Exclusion criteria
\- no FDA contraindications for use of NRT: 1. not pregnant, breastfeeding, or planning to become pregnant 2. no recent (past 3 months) cardiovascular trauma: MI, stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence | From study enrollment through end of six-month follow up |
Secondary
| Measure | Time frame |
|---|---|
| Any Self-defined Attempt to Stop Smoking Cigarettes | From study enrollment through end of six-month follow up |
| Use of Any Smoking Cessation Medication | From study enrollment through end of six-month follow up |
Countries
United States
Participant flow
Pre-assignment details
Of 1,278 Enrolled: 32 Individuals later found to be ineligible 1 person missing contact info 1,245 = Final Intent to Treat Sample
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Ask, Advise, Refer (physician brief advice) | 652 |
| Standard Care + Nicotine Replacement Therapy (NRT) 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)
Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch | 593 |
| Total | 1,245 |
Baseline characteristics
| Characteristic | Standard Care + Nicotine Replacement Therapy (NRT) | Total | Standard Care |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 13.4 | 50.7 years STANDARD_DEVIATION 13.5 | 51.0 years STANDARD_DEVIATION 13.6 |
| Heaviness of Smoking Index | 2.8 units on a scale STANDARD_DEVIATION 1.4 | 2.7 units on a scale STANDARD_DEVIATION 1.5 | 2.6 units on a scale STANDARD_DEVIATION 1.6 |
| Motivation to Quit | 6.4 units on a scale STANDARD_DEVIATION 3.6 | 6.3 units on a scale STANDARD_DEVIATION 3.65 | 6.2 units on a scale STANDARD_DEVIATION 3.7 |
| Race/Ethnicity, Customized White or African American African American | 160 Participants | 466 Participants | 306 Participants |
| Race/Ethnicity, Customized White or African American White | 433 Participants | 779 Participants | 346 Participants |
| Sex: Female, Male Female | 391 Participants | 756 Participants | 365 Participants |
| Sex: Female, Male Male | 202 Participants | 489 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 652 | 1 / 593 |
| other Total, other adverse events | 289 / 652 | 276 / 593 |
| serious Total, serious adverse events | 20 / 652 | 9 / 593 |
Outcome results
Primary
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence
Time frame: From study enrollment through end of six-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care + Nicotine Replacement Therapy (NRT) | Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence | 12 percentage of participants |
| Standard Care | Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence | 8 percentage of participants |
Secondary
Any Self-defined Attempt to Stop Smoking Cigarettes
Time frame: From study enrollment through end of six-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care + Nicotine Replacement Therapy (NRT) | Any Self-defined Attempt to Stop Smoking Cigarettes | 48 percentage of participants |
| Standard Care | Any Self-defined Attempt to Stop Smoking Cigarettes | 45 percentage of participants |
Secondary
Use of Any Smoking Cessation Medication
Time frame: From study enrollment through end of six-month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care + Nicotine Replacement Therapy (NRT) | Use of Any Smoking Cessation Medication | 25 percentage of participants |
| Standard Care | Use of Any Smoking Cessation Medication | 14 percentage of participants |