Trial Outcomes & Findings for Maintaining Nonsmoking (NCT NCT01162239)
NCT ID: NCT01162239
Last Updated: 2020-11-12
Results Overview
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) \< 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
12 weeks following treatment initiation
Results posted on
2020-11-12
Participant Flow
Participants were recruited from University of California, San Francisco medical clinics and the general community. Participants from the general community were recruited through flyers posted at various community health care organizations and social service agencies. Advertisements were placed in local newspapers and websites.
Participants were stratified based on gender, age, site, and number of cigarettes smoked per day at baseline. Participants were then randomly assigned to one of four treatment conditions derived from a double blinded allocation list prepared by a statistician. Neither participant nor the therapist were unblinded to final treatment until Week 8.
Participant milestones
| Measure |
Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Treatment Phase
STARTED
|
55
|
54
|
52
|
55
|
|
Treatment Phase
Week 12
|
50
|
51
|
49
|
53
|
|
Treatment Phase
Week 24
|
51
|
48
|
48
|
50
|
|
Treatment Phase
Week 52
|
49
|
47
|
48
|
50
|
|
Treatment Phase
COMPLETED
|
49
|
47
|
48
|
50
|
|
Treatment Phase
NOT COMPLETED
|
6
|
7
|
4
|
5
|
|
Extended Follow-up
STARTED
|
47
|
45
|
45
|
47
|
|
Extended Follow-up
COMPLETED
|
39
|
32
|
37
|
41
|
|
Extended Follow-up
NOT COMPLETED
|
8
|
13
|
8
|
6
|
Reasons for withdrawal
| Measure |
Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
1
|
3
|
2
|
3
|
|
Treatment Phase
Death
|
0
|
0
|
0
|
1
|
|
Treatment Phase
Lost to Follow-up
|
5
|
4
|
2
|
1
|
|
Extended Follow-up
Lost to Follow-up
|
8
|
13
|
8
|
6
|
Baseline Characteristics
Maintaining Nonsmoking
Baseline characteristics by cohort
| Measure |
Extended Brief Contact
n=55 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=54 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=52 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=55 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
53.8 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
47.3 years
STANDARD_DEVIATION 11.8 • n=483 Participants
|
48.9 years
STANDARD_DEVIATION 10.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
84 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
132 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
182 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
63 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
103 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=93 Participants
|
54 participants
n=4 Participants
|
52 participants
n=27 Participants
|
55 participants
n=483 Participants
|
216 participants
n=36 Participants
|
|
Number of cigarettes smoked per day
10 or less cigarettes smoked per day
|
14 participants
n=93 Participants
|
10 participants
n=4 Participants
|
14 participants
n=27 Participants
|
15 participants
n=483 Participants
|
55 participants
n=36 Participants
|
|
Number of cigarettes smoked per day
11 - 22 cigarettes smoked per day
|
32 participants
n=93 Participants
|
36 participants
n=4 Participants
|
31 participants
n=27 Participants
|
28 participants
n=483 Participants
|
54 participants
n=36 Participants
|
|
Number of cigarettes smoked per day
21 - 30 cigarettes smoked per day
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
2 participants
n=27 Participants
|
7 participants
n=483 Participants
|
52 participants
n=36 Participants
|
|
Number of cigarettes smoked per day
31 or more cigarettes smoked per day
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
55 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12 weeks following treatment initiationPoint prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) \< 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Outcome measures
| Measure |
Extended Brief Contact
n=50 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=51 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=49 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=53 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
|
22 Participants
|
20 Participants
|
29 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 24 weeks following treatment initiationPoint prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) \< 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Outcome measures
| Measure |
Extended Brief Contact
n=51 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=48 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=48 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=50 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
|
20 Participants
|
18 Participants
|
24 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 52 weeks following treatment initiationPoint prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) \< 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Outcome measures
| Measure |
Extended Brief Contact
n=49 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=47 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=48 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=50 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
|
19 Participants
|
15 Participants
|
23 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 64 weeks following treatment initiationPoint prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) \< 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Outcome measures
| Measure |
Extended Brief Contact
n=47 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=45 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=45 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=47 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
|
16 Participants
|
18 Participants
|
24 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 104 weeks following treatment initiationPoint prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) \< 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.
Outcome measures
| Measure |
Extended Brief Contact
n=39 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=32 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=37 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=40 Participants
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
|
16 Participants
|
13 Participants
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 weeks following treatment initiationThe three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.
Outcome measures
| Measure |
Extended Brief Contact
n=51 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=146 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Comparison of Combined Extended vs Brief Treatment at Week 24
|
20 Participants
|
63 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeks following treatment initiationThe three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.
Outcome measures
| Measure |
Extended Brief Contact
n=49 Participants
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=145 Participants
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Comparison of Combined Extended vs Brief Treatment at Week 52
|
19 Participants
|
55 Participants
|
—
|
—
|
Adverse Events
Extended Brief Contact
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Health Education
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Relapse Prevention Plus Varenicline
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Relapse Prevention
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Extended Brief Contact
n=55 participants at risk
Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff.
|
Extended Health Education
n=54 participants at risk
Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention Plus Varenicline
n=52 participants at risk
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
Extended Relapse Prevention
n=55 participants at risk
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
1.9%
1/52 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Nervous system disorders
Headache
|
1.8%
1/55 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
1.8%
1/55 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Psychiatric disorders
Confusion
|
1.8%
1/55 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Nervous system disorders
Concentration Impariment
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
1.8%
1/55 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Musculoskeletal and connective tissue disorders
Muscle Sprain
|
1.8%
1/55 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Injury, poisoning and procedural complications
Insect Bite
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
1.9%
1/52 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
1.9%
1/54 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
1.9%
1/54 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/55 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/54 • Up to 104 weeks
Only serious adverse events were collected for this study
|
0.00%
0/52 • Up to 104 weeks
Only serious adverse events were collected for this study
|
1.8%
1/55 • Number of events 1 • Up to 104 weeks
Only serious adverse events were collected for this study
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gary Humfleet, PhD
University of California, San Francisco
Phone: (415) 476-7674
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place