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

July 1, 2004
August 2, 2013
September 2001
March 2009   (final data collection date for primary outcome measure)
Participants Abstinent From Cigarettes [ Time Frame: Two years ] [ Designated as safety issue: No ]
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
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 was to examine pharmacological and psychological interventions for smokers over 50.

The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were 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 were 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 received 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment (NRT)

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

    There was 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 would continue receiving NRT for up to 52 weeks. Subjects in this condition would be encouraged to continue NRT through Week 24. If a subject terminated NRT and resumed smoking, before Week 50, would be instructed to set a quit 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 was identical to the Tailored/NRT condition except that no NRT was 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 was to prevent relapse. Secondary goal was to encourage initiation of abstinence for those who have not attained it by Week 12, and re-initiation of abstinence after slips. Subjects would participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session would occur at Week 10. Additional sessions would be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session would be 20-30 minutes long. Between sessions subjects would be contacted by phone for brief check-ins (5-10 minutes).
    Intervention: Drug: Nicotine polacrilex, Bupropion

*   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:

MULTIPLE

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
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
August 2013

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