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Maintaining Nonsmoking: Older Smokers - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00086385
First received: July 1, 2004
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: July 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Intervention: Drug: Nicotine polacrilex, Bupropion

  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
Subjects will be men and women, 50 years and older who smoke at least 10 cigarettes a day. They will respond to requests in the public media for individuals who are interested in quitting smoking, and will be referred from sources like UCSF Ambulatory Care Clinics, California Pacific General Medical Practice, and Jewish Family and Community Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant died at week 5 before randomization.

Reporting Groups
  Description
Brief Treatment

Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment

Brief Counseling - The counseling intervention consist of five 90-minute group meetings.

No further treatment during Weeks 12-52.

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Extended NRT

Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.

Counseling Treatment - This is identical to the Brief Counseling described above.

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Extended Tailored Counseling + NRT

Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Tailored/No Extended NRT

This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.


Participant Flow:   Overall Study
    Brief Treatment     Extended NRT     Extended Tailored Counseling + NRT     Tailored/No Extended NRT  
STARTED     100     99     104     99  
COMPLETED     98     97     103     98  
NOT COMPLETED     2     2     1     1  
Death                 2                 2                 1                 1  



  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.
No text entered.

Reporting Groups
  Description
Brief Treatment

Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment

Brief Counseling - The counseling intervention consist of five 90-minute group meetings.

No further treatment during Weeks 12-52.

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Extended NRT

Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.

Counseling Treatment - This is identical to the Brief Counseling described above.

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Extended Tailored Counseling + NRT

Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Tailored/No Extended NRT

This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.

Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Total Total of all reporting groups

Baseline Measures
    Brief Treatment     Extended NRT     Extended Tailored Counseling + NRT     Tailored/No Extended NRT     Total  
Number of Participants  
[units: participants]
  100     99     104     99     402  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     93     86     94     85     358  
>=65 years     7     13     10     14     44  
Age  
[units: years]
Mean ± Standard Deviation
  56.190  ± 5.40     56.97  ± 5.46     56.88  ± 6.82     56.63  ± 5.64     56.67  ± 5.85  
Gender  
[units: participants]
         
Female     41     40     39     41     161  
Male     59     59     65     58     241  
Region of Enrollment  
[units: participants]
         
United States     100     99     104     99     402  



  Outcome Measures

1.  Primary:   Participants Abstinent From Cigarettes   [ Time Frame: Two years ]


  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
The limitations of this study include generalizability, as the population treated was relatively well-educated, willing to participate in research and to attend treatment sessions.


  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: Sharon M. Hall, PhD
Organization: University of California, San Francisco
phone: 415-476-7574
e-mail: sharon.hall@ucsf.edu


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00086385     History of Changes
Other Study ID Numbers: NIDA-02538-1, R01DA002538, R01-02538-1
Study First Received: July 1, 2004
Results First Received: July 29, 2013
Last Updated: August 2, 2013
Health Authority: United States: Federal Government