Trial Outcomes & Findings for Smoking Cessation in Hispanic Construction Workers (NCT NCT02873377)
NCT ID: NCT02873377
Last Updated: 2019-11-07
Results Overview
Prolonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of \<15 ng/ml.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
134 participants
Primary outcome timeframe
6-month
Results posted on
2019-11-07
Participant Flow
Participant milestones
| Measure |
Enhanced Care
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Period 1: Enrollment
STARTED
|
65
|
69
|
|
Period 1: Enrollment
COMPLETED
|
65
|
69
|
|
Period 1: Enrollment
NOT COMPLETED
|
0
|
0
|
|
Period Title 2: 3 Months Follow up
STARTED
|
65
|
69
|
|
Period Title 2: 3 Months Follow up
COMPLETED
|
43
|
47
|
|
Period Title 2: 3 Months Follow up
NOT COMPLETED
|
22
|
22
|
|
Period Title 3: 6 Months Follow up
STARTED
|
65
|
69
|
|
Period Title 3: 6 Months Follow up
COMPLETED
|
50
|
46
|
|
Period Title 3: 6 Months Follow up
NOT COMPLETED
|
15
|
23
|
Reasons for withdrawal
| Measure |
Enhanced Care
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Period Title 2: 3 Months Follow up
Lost to Follow-up
|
22
|
22
|
|
Period Title 3: 6 Months Follow up
Lost to Follow-up
|
15
|
23
|
Baseline Characteristics
Smoking Cessation in Hispanic Construction Workers
Baseline characteristics by cohort
| Measure |
Enhanced Care
n=65 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=69 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
38.2 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
39.5 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
58 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-monthProlonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of \<15 ng/ml.
Outcome measures
| Measure |
Enhanced Care
n=50 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=46 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Prolonged Abstinence Rates
|
36.00 Percentage of participants
|
30.43 Percentage of participants
|
SECONDARY outcome
Timeframe: 6-monthPoint prevalence abstinence rates is defined as self report of not smoking; in the past 7 days not even a puff) confirmed by saliva cotinine level of \<15ng/ml.
Outcome measures
| Measure |
Enhanced Care
n=50 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=46 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
7-day Point- Prevalence Prolonged Abstinence Rate
|
36.00 Percentage of participants
|
30.43 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of workers screened
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
Outcome measures
| Measure |
Enhanced Care
n=156 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Enrollment Rate
Eligible Participants
|
85.9 Percentage of participants
|
—
|
|
Enrollment Rate
Randomized participants
|
85.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 6-monthQuitline Response will be reported by the percentage of participants that contacted the Quitline, enrolled in the tobacco Quitline and the participants that completed at least 1 phone call from Tobacco Quitline.
Outcome measures
| Measure |
Enhanced Care
n=65 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=69 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Quitline Response Rate
Contacted by tobacco Quitline
|
49.2 Percentage of participants
|
40.6 Percentage of participants
|
|
Quitline Response Rate
Enrolled in tobacco Quitline
|
29.23 Percentage of participants
|
23.19 Percentage of participants
|
|
Quitline Response Rate
Completed at least 1 phone calls from tobacco QL
|
23.08 Percentage of participants
|
11.59 Percentage of participants
|
SECONDARY outcome
Timeframe: 3-month, 6-monthFollow up rate will be reported as the percentage of participants that completed their follow up visit.
Outcome measures
| Measure |
Enhanced Care
n=65 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=69 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Follow-Up Rate
3-month follow-up
|
66.15 Percentage of participants
|
68.12 Percentage of participants
|
|
Follow-Up Rate
6-month follow-up
|
76.92 Percentage of participants
|
66.67 Percentage of participants
|
SECONDARY outcome
Timeframe: 6-monthQuestionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.
Outcome measures
| Measure |
Enhanced Care
n=65 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=69 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Questionnaire Response Rate
completed initial questionnaire
|
93.85 Percentage of participants
|
88.41 Percentage of participants
|
|
Questionnaire Response Rate
Completed follow-up questionnaire
|
76.92 Percentage of participants
|
66.67 Percentage of participants
|
SECONDARY outcome
Timeframe: 6-monthRate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.
Outcome measures
| Measure |
Enhanced Care
n=65 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=69 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Rate of Compliance to Intervention
2 weeks NRT from Quitline
|
15.38 Percentage of participants
|
13.04 Percentage of participants
|
|
Rate of Compliance to Intervention
Counseling session + 2 phone calls
|
43.08 Percentage of participants
|
88.40 Percentage of participants
|
|
Rate of Compliance to Intervention
6 weeks NRT
|
93.85 Percentage of participants
|
88.41 Percentage of participants
|
|
Rate of Compliance to Intervention
4 Quitline counseling sessions
|
6.15 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 6-monthFor the participants that did not quit, the change in number of cigarettes smoked will be reported as the number of cigarettes smoked per day at the 6 months follow up visit minus the number of cigarettes smoked per day at baseline
Outcome measures
| Measure |
Enhanced Care
n=50 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling \& Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call
|
Standard Care
n=46 Participants
Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.
Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Smoking Quitline Referral: Fax referral to the State smoking Quitline
|
|---|---|---|
|
Change in Number of Cigarettes Smoked
|
-13.5 Cigarettes smoked per day
Standard Deviation 1.5
|
-11.5 Cigarettes smoked per day
Standard Deviation 1.3
|
Adverse Events
Enhanced Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place