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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT00790569
First received: November 11, 2008
Last updated: December 12, 2013
Last verified: December 2013
Results First Received: December 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow for 2 periods

Period 1:   End of Treatment (6 Month Interview)
    Arm I     Arm II     Arm III  
STARTED     137     45     133  
COMPLETED     115     35     107  
NOT COMPLETED     22     10     26  
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 2:   End of Study (12 Month Interview)
    Arm I     Arm II     Arm III  
STARTED     137     45     133  
COMPLETED     71     26     83  
NOT COMPLETED     66     19     50  
Lost to Follow-up                 66                 19                 50  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible participants who completed enrollment and were randomized were included in baseline analyses.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Arm III     Total  
Number of Participants  
[units: participants]
  137     45     133     315  
Age  
[units: years]
Mean ± Standard Deviation
  39.2  ± 9.7     40.6  ± 10.6     40.3  ± 9.3     39.9  ± 9.7  
Gender  
[units: participants]
       
Female     74     17     68     159  
Male     63     28     65     156  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     2     3     3     8  
White     113     34     103     250  
More than one race     5     4     10     19  
Unknown or Not Reported     17     4     17     38  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     17     4     17     38  
Not Hispanic or Latino     120     41     116     277  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     137     45     133     315  
Years of Education  
[units: years]
Mean ± Standard Deviation
  11.8  ± 2.0     11.4  ± 1.9     11.9  ± 2.2     11.8  ± 1.9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   7-day Abstinence, Self-report   [ Time Frame: 6 Months ]

2.  Primary:   7-day Abstinence, CO-confirmed   [ Time Frame: 6-Months ]

3.  Primary:   Rates of Smoking Cessation Continuous   [ Time Frame: 6-Months ]

4.  Primary:   7-day Abstinence, Self-reported   [ Time Frame: 12 Months ]

5.  Primary:   7-day Abstinence, CO-confirmed   [ Time Frame: 12 Months ]

6.  Secondary:   Reduction in Cigarettes Per Day   [ Time Frame: 6-Months ]

7.  Secondary:   Smoking Urges   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Withdrawal Symptoms   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Retention in Methadone Maintenance   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Methadone Dose Changes   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Use of Illicit Drugs as Measured by Urine Toxicologies   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Reinforcing Effects of Smoking   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: michael_stein@brown.ed


No publications provided by Butler Hospital

Publications automatically indexed to this study:

Responsible Party: Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier: NCT00790569     History of Changes
Other Study ID Numbers: CDR0000616663, R01CA129226, BUTLER-0807-004
Study First Received: November 11, 2008
Results First Received: December 12, 2013
Last Updated: December 12, 2013
Health Authority: United States: Federal Government