Trial Outcomes & Findings for Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking (NCT NCT00790569)
NCT ID: NCT00790569
Last Updated: 2018-06-06
Results Overview
Number of participants with self-reported, 7-day abstinence at 6-months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
315 participants
Primary outcome timeframe
6 Months
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
End of Treatment (6 Month Interview)
STARTED
|
137
|
45
|
133
|
|
End of Treatment (6 Month Interview)
COMPLETED
|
115
|
35
|
107
|
|
End of Treatment (6 Month Interview)
NOT COMPLETED
|
22
|
10
|
26
|
|
End of Study (12 Month Interview)
STARTED
|
137
|
45
|
133
|
|
End of Study (12 Month Interview)
COMPLETED
|
71
|
26
|
83
|
|
End of Study (12 Month Interview)
NOT COMPLETED
|
66
|
19
|
50
|
Reasons for withdrawal
| Measure |
Arm I
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
End of Treatment (6 Month Interview)
Lost to Follow-up
|
20
|
8
|
20
|
|
End of Treatment (6 Month Interview)
Death
|
0
|
2
|
1
|
|
End of Treatment (6 Month Interview)
Hospitalized
|
2
|
0
|
0
|
|
End of Treatment (6 Month Interview)
Residential Treatment
|
0
|
0
|
2
|
|
End of Treatment (6 Month Interview)
Incarcerated
|
0
|
0
|
3
|
|
End of Study (12 Month Interview)
Lost to Follow-up
|
66
|
19
|
50
|
Baseline Characteristics
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
Baseline characteristics by cohort
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
137 participants
n=5 Participants
|
45 participants
n=7 Participants
|
133 participants
n=5 Participants
|
315 participants
n=4 Participants
|
|
Years of Education
|
11.8 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
11.4 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
11.9 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
11.8 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsNumber of participants with self-reported, 7-day abstinence at 6-months
Outcome measures
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Self- Reported 7-day Abstinence
|
11 participants
|
3 participants
|
16 participants
|
PRIMARY outcome
Timeframe: 6-MonthsNumber of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
Outcome measures
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
|
5 participants
|
1 participants
|
11 participants
|
PRIMARY outcome
Timeframe: 6-MonthsNumber of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
Outcome measures
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
|
2 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 12 MonthsNumber of participants with self-reported 7-day abstinence at 12-months
Outcome measures
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Self-reported 7-day Abstinence
|
4 participants
|
3 participants
|
11 participants
|
PRIMARY outcome
Timeframe: 12 MonthsNumber of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
Outcome measures
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
CO-confirmed 7-day Abstinence
|
4 participants
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 6 monthsSmoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
Outcome measures
| Measure |
Arm I
n=89 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=26 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=86 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Change in Smoking Urges
|
-29.971 units on a scale
Standard Deviation 39.120
|
-25.015 units on a scale
Standard Deviation 31.689
|
-24.177 units on a scale
Standard Deviation 37.015
|
SECONDARY outcome
Timeframe: 6 monthsWithdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.
Outcome measures
| Measure |
Arm I
n=88 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=26 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=86 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Withdrawal Symptoms
|
-.222 units on a scale
Standard Deviation .618
|
-.163 units on a scale
Standard Deviation .447
|
-.113 units on a scale
Standard Deviation .564
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsReinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.
Outcome measures
| Measure |
Arm I
n=81 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=25 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=75 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Reinforcing Effects of Smoking
|
-1.005 units on a scale
Standard Deviation 1.173
|
-.683 units on a scale
Standard Deviation .865
|
-.761 units on a scale
Standard Deviation .957
|
SECONDARY outcome
Timeframe: 6-MonthsChange in mean cigarettes per day
Outcome measures
| Measure |
Arm I
n=137 Participants
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 Participants
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 Participants
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Change in Cigarettes Per Day
|
-8.7 cigarettes/day
Standard Deviation 9.2
|
-8.5 cigarettes/day
Standard Deviation 9.5
|
-7.8 cigarettes/day
Standard Deviation 9.4
|
Adverse Events
Arm I
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm III
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=137 participants at risk
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
varenicline: Given orally
|
Arm II
n=45 participants at risk
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.
placebo: Given orally
|
Arm III
n=133 participants at risk
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.
nicotine: Given transdermally and orally
|
|---|---|---|---|
|
Psychiatric disorders
Neurobehavioral Adverse Effects
|
0.73%
1/137 • Number of events 1
|
0.00%
0/45
|
0.00%
0/133
|
|
Psychiatric disorders
Neurobehavioral Adverse Events
|
0.73%
1/137 • Number of events 1
|
0.00%
0/45
|
0.00%
0/133
|
|
General disorders
Participant Death
|
0.00%
0/137
|
4.4%
2/45 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/137
|
0.00%
0/45
|
0.75%
1/133 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
1.5%
2/137 • Number of events 2
|
0.00%
0/45
|
0.00%
0/133
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place