Maintaining Nonsmoking: Older Smokers
Overview
- Phase
- Phase 3
- Intervention
- Nicotine polacrilex, Bupropion
- Conditions
- Tobacco Use Disorder
- Sponsor
- University of California, San Francisco
- Enrollment
- 403
- Locations
- 1
- Primary Endpoint
- Participants Abstinent From Cigarettes
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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: Nicotine polacrilex, Bupropion
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: Nicotine polacrilex, Bupropion
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: Nicotine polacrilex, Bupropion
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: Nicotine polacrilex, Bupropion
Outcomes
Primary Outcomes
Participants Abstinent From Cigarettes
Time Frame: Two years
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104