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Maintaining Nonsmoking: Older Smokers - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nicotine polacrilex, Bupropion
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking cessation, Tobacco

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

smokers of at least 10 cigarettes per day Inclusion Criteria: MULTIPLE Exclusion Criteria: MULTIPLE

Sites / Locations

  • San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Brief Treatment

Extended NRT

Tailored/No Extended NRT

Extended Tailored Counseling + NRT

Arm 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.

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.

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

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).

Outcomes

Primary Outcome Measures

Participants Abstinent From Cigarettes
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104

Secondary Outcome Measures

Full Information

First Posted
July 1, 2004
Last Updated
March 3, 2015
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00086385
Brief Title
Maintaining Nonsmoking: Older Smokers - 1
Official Title
Maintaining Nonsmoking: Older Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking cessation, Tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Extended NRT
Arm Type
Experimental
Arm 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.
Arm Title
Tailored/No Extended NRT
Arm Type
Experimental
Arm Description
This condition was identical to the Tailored/NRT condition except that no NRT was available after completion of the Brief Treatment.
Arm Title
Extended Tailored Counseling + NRT
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Nicotine polacrilex, Bupropion
Other Intervention Name(s)
Nicorette, Zyban
Intervention Description
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Primary Outcome Measure Information:
Title
Participants Abstinent From Cigarettes
Description
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
smokers of at least 10 cigarettes per day Inclusion Criteria: MULTIPLE Exclusion Criteria: MULTIPLE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon M Hall, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24329972
Citation
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.
Results Reference
derived
PubMed Identifier
19392908
Citation
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. Erratum In: Addiction. 2011 Jun;106(6):1204.
Results Reference
derived

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Maintaining Nonsmoking: Older Smokers - 1

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