Trial Outcomes & Findings for A Smoking Cessation Treatment for Adult Women (NCT NCT01422239)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2020-04-20

Participant Flow

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

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).

Participant milestones

Participant milestones
Measure	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, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.	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 smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
Overall Study STARTED	14	6
Overall Study COMPLETED	10	3
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.	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 smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

A Smoking Cessation Treatment for Adult Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tailored Behavioral Counseling n=14 Participants 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.	Standard Behavioral Counseling n=6 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	6 Participants n=4 Participants	20 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	43.9 years STANDARD_DEVIATION 8.4 • n=93 Participants	45.8 years STANDARD_DEVIATION 13.3 • n=4 Participants	44.5 years STANDARD_DEVIATION 9.8 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	6 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	6 participants n=4 Participants	20 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: Participants who dropped out of the study were considered to be smoking.

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)

Outcome measures

Outcome measures
Measure	Tailored Behavioral Counseling n=14 Participants 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.	Standard Behavioral Counseling n=6 Participants 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.
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels	4 participants	1 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: participants who did not complete the appointment were considered to be smoking

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)

Outcome measures

Outcome measures
Measure	Tailored Behavioral Counseling n=14 Participants 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.	Standard Behavioral Counseling n=6 Participants 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.
Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels	2 participants	1 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Tailored Behavioral Counseling n=6 Participants 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.	Standard Behavioral Counseling n=2 Participants 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.
Change in Smoking From Baseline to the Followup Assessment (Week 12)	4.4 CPD Standard Deviation 5.4	2.0 CPD Standard Deviation 1.5

Adverse Events

Tailored Behavioral Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Behavioral Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea Weinberger, Ph.D.

Yale University School of Medicine

Phone: 203-974-7598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place