Maintaining Nonsmoking: Older Smokers - 1
3 other identifiers
interventional
403
1 country
1
Brief Summary
The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
July 1, 2004
CompletedFirst Posted
Study publicly available on registry
July 7, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
October 10, 2013
CompletedMarch 23, 2015
March 1, 2015
7.5 years
July 1, 2004
July 29, 2013
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants Abstinent From Cigarettes
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
Two years
Study Arms (4)
Brief Treatment
ACTIVE COMPARATORPharmacological 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.
Extended NRT
EXPERIMENTALPharmacological 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.
Tailored/No Extended NRT
EXPERIMENTALThis condition was identical to the Tailored/NRT condition except that no NRT was available after completion of the Brief Treatment.
Extended Tailored Counseling + NRT
EXPERIMENTALTailored 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).
Interventions
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Eligibility Criteria
You may qualify if:
- MULTIPLE
You may not qualify if:
- MULTIPLE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco
San Francisco, California, 94143, United States
Related Publications (4)
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.
PMID: 39868569DERIVEDTheodoulou 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.
PMID: 37335995DERIVEDBarnett 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.
PMID: 24329972DERIVEDHall 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.
PMID: 19392908DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The limitations of this study include generalizability, as the population treated was relatively well-educated, willing to participate in research and to attend treatment sessions.
Results Point of Contact
- Title
- Sharon M. Hall, PhD
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon M Hall, Ph.D.
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2004
First Posted
July 7, 2004
Study Start
September 1, 2001
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 23, 2015
Results First Posted
October 10, 2013
Record last verified: 2015-03