Maintaining Nonsmoking: Older Smokers - 1

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3

Conditions: Tobacco Use Disorder

Treatments: Drug: Nicotine polacrilex, Bupropion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00086385

R01-02538-1

R01DA002538 (U.S. NIH Grant/Contract)

NIDA-02538-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 403 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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403 participants in 4 patient groups

Brief Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine polacrilex, Bupropion

Extended NRT

Experimental group

Description:

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.

Treatment:

Drug: Nicotine polacrilex, Bupropion

Tailored/No Extended NRT

Experimental group

Description:

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

Treatment:

Drug: Nicotine polacrilex, Bupropion

Extended Tailored Counseling + NRT

Experimental group

Description:

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).

Treatment:

Drug: Nicotine polacrilex, Bupropion