Nicotine Dependence
Conditions
Keywords
smoking, treatment, perceived risks
Brief summary
The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment). Aim 1: To develop the risk-based smoking cessation intervention. Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking. Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.
Detailed description
The purpose of this treatment development study is to design and pilot test a smoking cessation intervention in which counseling sessions are tailored to individual smokers' perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel treatment will be examined through a pilot study in which female smokers will be randomly assigned to receive either the tailored treatment or a standard treatment. It is expected that participants receiving the tailored treatment will show higher rates of smoking abstinence than participants receiving the standard smoking cessation treatment at the end of the 8-week treatment and at one month follow-up.
Interventions
BEHAVIORALTailored treatment
8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
BEHAVIORALStandard Treatment
8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
Sponsors
National Institutes of Health (NIH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 64 years old * Meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for nicotine dependence with Fagerström Test for Nicotine Dependence (FTND) score ≥4 * Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath carbon monoxide (CO) level ≥10 * At the time of initial evaluation, are motivated to quit smoking in the next 30 days. * Have the capacity to give informed consent, and are English-speaking.
Exclusion criteria
* Have a positive urine drug screen or urine pregnancy test at baseline evaluation * Meet DSM-IV criteria for alcohol or other drug abuse or dependence in the previous 6 months * Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder * Meet DSM-IV criteria for a current or past diagnosis of bipolar disorder or schizophrenia * Are currently receiving treatment for nicotine dependence (e.g., nicotine replacement therapy, bupropion, chantix)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels | Up to 8 weeks | point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels \< 5ppm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels | 12 weeks | point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels \< 5ppm) |
| Change in Smoking From Baseline to the Followup Assessment (Week 12) | Week 0 (baseline), Week 12 (one month followup) | Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study. |
Countries
United States
Participant flow
Recruitment details
Recruitment of participants began in August of 2011 an ended in September 2012. Recruitment methods included radio advertisements, ClinicalTrials.gov, Craig's List postings, flyers, and referrals from research colleagues in the Department of Psychiatry
Pre-assignment details
28 adults signed the consent form and 20 adults were randomized and began the study. The 8 participants who completed the consent procedures but were not randomized were either not eligible (drug use, n=3; psychiatric diagnoses, n=2; low smoking, n=1) or did not attend the first study appointment and did not respond to attempts to contact (n=2).
Participants by arm
| Arm | Count |
|---|---|
| Tailored Behavioral Counseling The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting. | 14 |
| Standard Behavioral Counseling The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual. | 6 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
Baseline characteristics
| Characteristic | Total | Tailored Behavioral Counseling | Standard Behavioral Counseling |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 14 Participants | 6 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 9.8 | 43.9 years STANDARD_DEVIATION 8.4 | 45.8 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 20 participants | 14 participants | 6 participants |
| Sex: Female, Male Female | 20 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 6 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 |
Outcome results
Primary
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels
point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels \< 5ppm)
Time frame: Up to 8 weeks
Population: Participants who dropped out of the study were considered to be smoking.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Behavioral Counseling | Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels | 4 participants |
| Standard Behavioral Counseling | Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels | 1 participants |
Secondary
Change in Smoking From Baseline to the Followup Assessment (Week 12)
Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.
Time frame: Week 0 (baseline), Week 12 (one month followup)
Population: Participants who completed the week 8 appointment and provided the number of cigarettes smoked per day were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Behavioral Counseling | Change in Smoking From Baseline to the Followup Assessment (Week 12) | 4.4 CPD | Standard Deviation 5.4 |
| Standard Behavioral Counseling | Change in Smoking From Baseline to the Followup Assessment (Week 12) | 2.0 CPD | Standard Deviation 1.5 |
Secondary
Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels
point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels \< 5ppm)
Time frame: 12 weeks
Population: participants who did not complete the appointment were considered to be smoking
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tailored Behavioral Counseling | Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels | 2 participants |
| Standard Behavioral Counseling | Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels | 1 participants |