Tobacco Use Disorder
Conditions
Keywords
Smoking cessation, Tobacco
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.
Interventions
DRUGNicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
smokers of at least 10 cigarettes per day Inclusion Criteria: MULTIPLE
Exclusion criteria
MULTIPLE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Abstinent From Cigarettes | Two years | Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104 |
Countries
United States
Participant flow
Recruitment details
Subjects will be men and women, 50 years and older who smoke at least 10 cigarettes a day. They will respond to requests in the public media for individuals who are interested in quitting smoking, and will be referred from sources like UCSF Ambulatory Care Clinics, California Pacific General Medical Practice, and Jewish Family and Community Center.
Pre-assignment details
One participant died at week 5 before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Brief Treatment Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment
Brief Counseling - The counseling intervention consist of five 90-minute group meetings.
No further treatment during Weeks 12-52.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement. | 100 |
| Extended NRT Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement. | 99 |
| Extended Tailored Counseling + NRT Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement. | 104 |
| Tailored/No Extended NRT This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.
Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement. | 99 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Tailored/No Extended NRT | Total | Extended NRT | Brief Treatment | Extended Tailored Counseling + NRT |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 44 Participants | 13 Participants | 7 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 358 Participants | 86 Participants | 93 Participants | 94 Participants |
| Age, Continuous | 56.63 years STANDARD_DEVIATION 5.64 | 56.67 years STANDARD_DEVIATION 5.85 | 56.97 years STANDARD_DEVIATION 5.46 | 56.190 years STANDARD_DEVIATION 5.4 | 56.88 years STANDARD_DEVIATION 6.82 |
| Region of Enrollment United States | 99 participants | 402 participants | 99 participants | 100 participants | 104 participants |
| Sex: Female, Male Female | 41 Participants | 161 Participants | 40 Participants | 41 Participants | 39 Participants |
| Sex: Female, Male Male | 58 Participants | 241 Participants | 59 Participants | 59 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 100 | 3 / 99 | 4 / 104 | 3 / 99 |
| serious Total, serious adverse events | 2 / 100 | 5 / 99 | 4 / 104 | 2 / 99 |
Outcome results
Primary
Participants Abstinent From Cigarettes
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
Time frame: Two years
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Brief Treatment | Participants Abstinent From Cigarettes | 31 participants | 5.4 |
| Extended NRT | Participants Abstinent From Cigarettes | 35 participants | 6.82 |
| Extended Tailored Counseling + NRT | Participants Abstinent From Cigarettes | 39 participants | 5.64 |
| Tailored/No Extended NRT | Participants Abstinent From Cigarettes | 45 participants | 5.46 |