Maintaining Nonsmoking: Older Smokers - 1

Maintaining Nonsmoking: Older Smokers

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Nicotine polacrilex, Bupropion

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.

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Nicotine polacrilex, Bupropion; Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.; Other Names: Nicorette, Zyban
Experimental: 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.	Drug: Nicotine polacrilex, Bupropion; Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.; Other Names: Nicorette, Zyban
Experimental: 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.	Drug: Nicotine polacrilex, Bupropion; Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.; Other Names: Nicorette, Zyban
Experimental: 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).	Drug: Nicotine polacrilex, Bupropion; Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.; Other Names: Nicorette, Zyban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Abstinent From Cigarettes	Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104	Two years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sharon M Hall, Ph.D., University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: July 1, 2004
• First Submitted That Met QC Criteria: July 6, 2004
• First Posted (Estimate): July 7, 2004

Study Record Updates

• Last Update Posted (Estimate): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Smoking cessation; Tobacco
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion
• Other Study ID Numbers: NIDA-02538-1; R01DA002538 (U.S. NIH Grant/Contract); R01-02538-1