Maintaining Nonsmoking: Older Smokers - 1

NCT ID: NCT00086385

Last Updated: 2015-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2009-03-31

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nicotine polacrilex, Bupropion

Intervention Type: DRUG

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 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.

Group Type: EXPERIMENTAL

Nicotine polacrilex, Bupropion

Intervention Type: DRUG

Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

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.

Group Type: EXPERIMENTAL

Nicotine polacrilex, Bupropion

Intervention Type: DRUG

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 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).

Group Type: EXPERIMENTAL

Nicotine polacrilex, Bupropion

Intervention Type: DRUG

Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Interventions

Nicotine polacrilex, Bupropion

Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Intervention Type: DRUG

Other Intervention Names

Nicorette, Zyban

Eligibility Criteria

Inclusion Criteria

MULTIPLE

Exclusion Criteria

MULTIPLE

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon M Hall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco

San Francisco, California, United States

Countries

United States

References

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

Reference Type: DERIVED

PMID: 37335995 (View on PubMed)

Barnett PG, Wong W, Jeffers A, Munoz R, Humfleet G, Hall S. Cost-effectiveness of extended cessation treatment for older smokers. Addiction. 2014 Feb;109(2):314-22. doi: 10.1111/add.12404. Epub 2013 Dec 13.

Reference Type: DERIVED

PMID: 24329972 (View on PubMed)

Hall SM, Humfleet GL, Munoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. doi: 10.1111/j.1360-0443.2009.02548.x. Epub 2009 Apr 9.

Reference Type: DERIVED

PMID: 19392908 (View on PubMed)

Other Identifiers

R01DA002538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-02538-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-02538-1

Identifier Type: -

Identifier Source: org_study_id