Trial Outcomes & Findings for Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms (NCT NCT00578669)
NCT ID: NCT00578669
Last Updated: 2018-10-16
Results Overview
7-day point prevalence abstinence
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
One year
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
Sequential Fluoxetine
Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.
Fluoxetine was used once daily for 16 weeks.
|
Sequential Placebo
Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
Dextrose was used once daily for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
99
|
|
Overall Study
COMPLETED
|
107
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Sequential Placebo
n=99 Participants
Participants received placebo medication, dextrose, that was begun 8 weeks prior to and extended throughout the brief, behavioral standard smoking cessation treatment that included transdermal nicotine patch.
The placebo medication (dextrose) was taken once daily for 16 weeks.
|
Sequential Fluoxetine
n=107 Participants
Participants received fluoxetine medication, 20 mg, that was begun 8 weeks prior to and extended throughout the brief, behavioral standard smoking cessation treatment that included transdermal nicotine patch.
The fluoxetine medication (20 mg) was taken once daily for 16 weeks.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.05 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
43.07 years
STANDARD_DEVIATION 10.97 • n=7 Participants
|
43.54 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
107 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Cigarettes smoked per day (past month)
|
21.07 cigarettes
STANDARD_DEVIATION 9.03 • n=5 Participants
|
20.96 cigarettes
STANDARD_DEVIATION 10.33 • n=7 Participants
|
21.01 cigarettes
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND)
|
5.40 units on a scale
STANDARD_DEVIATION 2.37 • n=5 Participants
|
5.90 units on a scale
STANDARD_DEVIATION 1.74 • n=7 Participants
|
5.66 units on a scale
STANDARD_DEVIATION 2.08 • n=5 Participants
|
|
Center for Epidemiologic Studies - Depression (CES-D) scale
|
9.64 units on a scale
STANDARD_DEVIATION 8.53 • n=5 Participants
|
9.90 units on a scale
STANDARD_DEVIATION 8.14 • n=7 Participants
|
9.77 units on a scale
STANDARD_DEVIATION 8.31 • n=5 Participants
|
|
Center for Epidemiologic Studies - Depression (CES-D) > 16
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Recurrent major depressive disorder (MDD)
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Single major depressive disorder (MDD) episode
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year7-day point prevalence abstinence
Outcome measures
| Measure |
Sequential Fluoxetine
n=107 Participants
Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.
Fluoxetine was used once daily for 16 weeks.
|
Sequential Placebo
n=99 Participants
Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
Dextrose was used once daily for 16 weeks
|
|---|---|---|
|
Number of Participants Achieving Smoking Abstinence
|
24 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: One yearSelf-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms.
Outcome measures
| Measure |
Sequential Fluoxetine
n=107 Participants
Sequential Fluoxetine - Participants received sequential antidepressant pharmacotherapy (fluoxetine - 20 mg.) that was begun 8 weeks prior to, and extended throughout the treatment phase. The treatment phase consisted of 8 weeks of brief behavioral counseling and transdermal nicotine patches.
Fluoxetine was used once daily for 16 weeks.
|
Sequential Placebo
n=99 Participants
Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout the 8-week brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
Dextrose was used once daily for 16 weeks
|
|---|---|---|
|
Self-reported Depressive Symptoms
|
9.9 score on a scale
Standard Deviation 8.14
|
9.64 score on a scale
Standard Deviation 8.53
|
Adverse Events
Sequential Fluoxetine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sequential Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sequential Fluoxetine
n=107 participants at risk
Sequential antidepressant pharmacotherapy with (20mg) fluoxetine, begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
Fluoxetine: 20mg once daily for 16 weeks
|
Sequential Placebo
n=99 participants at risk
Sequential placebo medication (dextrose), begun 8 weeks prior to and extended throughout brief (behavioral) standard smoking cessation treatment with transdermal nicotine patch.
Dextrose: Once daily for 16 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.93%
1/107 • Number of events 1 • Adverse event data were collected over a one year period.
Definitions of adverse event and/or serious adverse event do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/99 • Adverse event data were collected over a one year period.
Definitions of adverse event and/or serious adverse event do not differ from the clinicaltrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place