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Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

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ClinicalTrials.gov Identifier: NCT00790569
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : February 3, 2014
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Interventions Drug: nicotine
Drug: varenicline
Other: placebo
Enrollment 315
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description

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

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

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

Period Title: End of Treatment (6 Month Interview)
Started 137 45 133
Completed 115 35 107
Not Completed 22 10 26
Reason Not Completed
Lost to Follow-up             20             8             20
Death             0             2             1
Hospitalized             2             0             0
Residential Treatment             0             0             2
Incarcerated             0             0             3
Period Title: End of Study (12 Month Interview)
Started 137 45 133
Completed 71 26 83
Not Completed 66 19 50
Reason Not Completed
Lost to Follow-up             66             19             50
Arm/Group Title Arm I Arm II Arm III Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 137 45 133 315
Hide Baseline Analysis Population Description
All eligible participants who completed enrollment and were randomized were included in baseline analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 45 participants 133 participants 315 participants
39.2  (9.7) 40.6  (10.6) 40.3  (9.3) 39.9  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 45 participants 133 participants 315 participants
Female
74
  54.0%
17
  37.8%
68
  51.1%
159
  50.5%
Male
63
  46.0%
28
  62.2%
65
  48.9%
156
  49.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 45 participants 133 participants 315 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.5%
3
   6.7%
3
   2.3%
8
   2.5%
White
113
  82.5%
34
  75.6%
103
  77.4%
250
  79.4%
More than one race
5
   3.6%
4
   8.9%
10
   7.5%
19
   6.0%
Unknown or Not Reported
17
  12.4%
4
   8.9%
17
  12.8%
38
  12.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 45 participants 133 participants 315 participants
Hispanic or Latino
17
  12.4%
4
   8.9%
17
  12.8%
38
  12.1%
Not Hispanic or Latino
120
  87.6%
41
  91.1%
116
  87.2%
277
  87.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 137 participants 45 participants 133 participants 315 participants
137 45 133 315
Years of Education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 45 participants 133 participants 315 participants
11.8  (2.0) 11.4  (1.9) 11.9  (2.2) 11.8  (1.9)
1.Primary Outcome
Title Self- Reported 7-day Abstinence
Hide Description Number of participants with self-reported, 7-day abstinence at 6-months
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 137 45 133
Measure Type: Number
Unit of Measure: participants
11 3 16
2.Primary Outcome
Title Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Hide Description Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
Time Frame 6-Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 137 45 133
Measure Type: Number
Unit of Measure: participants
5 1 11
3.Primary Outcome
Title Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
Hide Description Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
Time Frame 6-Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 137 45 133
Measure Type: Number
Unit of Measure: participants
2 0 2
4.Primary Outcome
Title Self-reported 7-day Abstinence
Hide Description Number of participants with self-reported 7-day abstinence at 12-months
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 137 45 133
Measure Type: Number
Unit of Measure: participants
4 3 11
5.Primary Outcome
Title CO-confirmed 7-day Abstinence
Hide Description Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 137 45 133
Measure Type: Number
Unit of Measure: participants
4 1 8
6.Secondary Outcome
Title Change in Smoking Urges
Hide Description Smoking 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 89 26 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
-29.971  (39.120) -25.015  (31.689) -24.177  (37.015)
7.Secondary Outcome
Title Withdrawal Symptoms
Hide Description Withdrawal 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 88 26 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
-.222  (.618) -.163  (.447) -.113  (.564)
8.Secondary Outcome
Title Retention in Methadone Maintenance
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Methadone Dose Changes
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Use of Illicit Drugs as Measured by Urine Toxicologies
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Reinforcing Effects of Smoking
Hide Description Reinforcing 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 81 25 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.005  (1.173) -.683  (.865) -.761  (.957)
12.Secondary Outcome
Title Change in Cigarettes Per Day
Hide Description Change in mean cigarettes per day
Time Frame 6-Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 137 45 133
Mean (Standard Deviation)
Unit of Measure: cigarettes/day
-8.7  (9.2) -8.5  (9.5) -7.8  (9.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II Arm III
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Arm I Arm II Arm III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II Arm III
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/137 (2.92%)      2/45 (4.44%)      2/133 (1.50%)    
Cardiac disorders       
Heart Attack [1]  0/137 (0.00%)  0 0/45 (0.00%)  0 1/133 (0.75%)  1
General disorders       
Participant Death [2]  0/137 (0.00%)  0 2/45 (4.44%)  2 1/133 (0.75%)  1
Psychiatric disorders       
Neurobehavioral Adverse Effects [3]  1/137 (0.73%)  1 0/45 (0.00%)  0 0/133 (0.00%)  0
Neurobehavioral Adverse Events [4]  1/137 (0.73%)  1 0/45 (0.00%)  0 0/133 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin Rash [5]  2/137 (1.46%)  2 0/45 (0.00%)  0 0/133 (0.00%)  0
[1]
Participant was hospitalized with symptoms of heat attack
[2]
Participant died during study participation
[3]
Participant described hearing voices
[4]
Participant reported mood disturbance
[5]
Participants complained of skin rashes
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II Arm III
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/137 (0.00%)      0/45 (0.00%)      0/133 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michael Stein
Organization: Butler Hospital
Phone: 401-455-6646
Responsible Party: Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier: NCT00790569     History of Changes
Other Study ID Numbers: CDR0000616663
R01CA129226 ( U.S. NIH Grant/Contract )
BUTLER-0807-004
First Submitted: November 11, 2008
First Posted: November 13, 2008
Results First Submitted: December 12, 2013
Results First Posted: February 3, 2014
Last Update Posted: June 5, 2018