Maintaining Nonsmoking: Older Smokers - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon Hall, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00086385
First received: July 1, 2004
Last updated: January 30, 2013
Last verified: January 2013

July 1, 2004
January 30, 2013
September 2001
March 2009   (final data collection date for primary outcome measure)
Biochemically verified abstinence from cigarettes. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Smoking Behavior
Complete list of historical versions of study NCT00086385 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Maintaining Nonsmoking: Older Smokers - 1
Maintaining Nonsmoking: Older Smokers

The purpose of this study is to examine pharmacological and psychological interventions for smokers over 50.

The overall goals of this line of research are to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study are to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression.Participants are 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Use Disorder
Drug: Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Other Name: Nicorette, Zyban
  • Active Comparator: 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.

    Intervention: Drug: Nicotine polacrilex, Bupropion
  • Experimental: 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.

    Intervention: Drug: Nicotine polacrilex, Bupropion
  • Experimental: 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.
    Intervention: Drug: Nicotine polacrilex, Bupropion
  • Experimental: 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).
    Intervention: Drug: Nicotine polacrilex, Bupropion
Hall SM, Humfleet GL, Muñoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. Epub 2009 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
March 2009
March 2009   (final data collection date for primary outcome measure)

smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIIPLE

Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086385
NIDA-02538-1, R01DA002538, R01-02538-1
No
Sharon Hall, University of California, San Francisco
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Principal Investigator: Sharon M Hall, Ph.D. University of California, San Francisco
University of California, San Francisco
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP