Trial Outcomes & Findings for Smoking Cessation Using Motivational Therapy and Varenicline (NCT NCT00701896)
NCT ID: NCT00701896
Last Updated: 2021-01-15
Results Overview
To determine the safety and tolerability of varenicline compared to nicotine replacement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
294 participants
Primary outcome timeframe
3 months
Results posted on
2021-01-15
Participant Flow
Participant milestones
| Measure |
Nicotine Replacement Plus Motivational Interviewing
PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)
|
Varenicline Plus Motivational Interviewing
PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
151
|
|
Overall Study
COMPLETED
|
110
|
118
|
|
Overall Study
NOT COMPLETED
|
33
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation Using Motivational Therapy and Varenicline
Baseline characteristics by cohort
| Measure |
Nicotine Replacement Plus Motivational Interviewing
n=110 Participants
PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)
|
Varenicline Plus Motivational Interviewing
n=118 Participants
PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.7 years
n=5 Participants
|
42.8 years
n=7 Participants
|
42.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Three-month abstinence rates among participants who received NRT were compared with those who received varenicline. Although some participants stopped taking the pharmacotherapy, or switched from varenicline to NRT, for the analysis , they were kept in their initial group. Because treatment assignment was not random, inverse probability of treatment weighting (IPTW) adjustment was performed. A propensity score was estimated as the probability of receiving varenicline, given measured covariates
To determine the safety and tolerability of varenicline compared to nicotine replacement
Outcome measures
| Measure |
Nicotine Replacement Plus Motivational Interviewing
n=110 Participants
PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)
|
Varenicline Plus Motivational Interviewing
n=118 Participants
PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily
|
|---|---|---|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Skin rash
|
17 Participants
|
0 Participants
|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Nausea
|
13 Participants
|
38 Participants
|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Vomiting
|
3 Participants
|
4 Participants
|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Insomnia
|
11 Participants
|
8 Participants
|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Vivid dreams
|
11 Participants
|
27 Participants
|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Suicidal ideation
|
0 Participants
|
1 Participants
|
|
To Determine the Safety of Varenicline in PLWH Who Smoke
Depressed mood
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Abstinence rates among participants who received NRT were compared with those who received varenicline. Although some participants stopped taking the pharmacotherapy, or switched from varenicline to NRT, for the analysis , they were kept in their initial group. Because treatment assignment was not random, inverse probability of treatment weighting (IPTW) adjustment was performed. A propensity score was estimated as the probability of receiving varenicline, given measured covariates
To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline
Outcome measures
| Measure |
Nicotine Replacement Plus Motivational Interviewing
n=110 Participants
PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)
|
Varenicline Plus Motivational Interviewing
n=118 Participants
PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily
|
|---|---|---|
|
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
3 month biochemically confirmed abstinence rate
|
13 Participants
|
30 Participants
|
|
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
6 month biochemically confirmed abstinence rate
|
5 Participants
|
19 Participants
|
|
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
12 month biochemically confirmed abstinence rate
|
4 Participants
|
18 Participants
|
Adverse Events
Nicotine Replacement Plus Motivational Interviewing
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Varenicline Plus Motivational Interviewing
Serious events: 1 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine Replacement Plus Motivational Interviewing
n=110 participants at risk
PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)
|
Varenicline Plus Motivational Interviewing
n=118 participants at risk
PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/110
|
0.85%
1/118
|
Other adverse events
| Measure |
Nicotine Replacement Plus Motivational Interviewing
n=110 participants at risk
PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg)
|
Varenicline Plus Motivational Interviewing
n=118 participants at risk
PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
15.5%
17/110 • Number of events 17
|
0.00%
0/118
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
5.5%
6/110
|
0.00%
0/118
|
|
Gastrointestinal disorders
Nausea
|
11.8%
13/110
|
32.2%
38/118
|
|
Psychiatric disorders
Insomnia
|
8.2%
9/110
|
17.8%
21/118
|
|
Psychiatric disorders
Vivid dreams
|
10.0%
11/110
|
22.9%
27/118
|
|
Psychiatric disorders
agitation
|
0.00%
0/110
|
10.2%
12/118
|
|
Nervous system disorders
headache
|
0.00%
0/110
|
7.6%
9/118
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/110
|
9.3%
11/118
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place