Trial Outcomes & Findings for Varenicline for Nicotine Dependence Among Those With HIV/AIDS (NCT NCT01710137)

NCT ID: NCT01710137

Last Updated: 2019-09-18

Results Overview

7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 179 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2019-09-18

Participant Flow

Participant milestones

Measure	Varenicline 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Overall Study STARTED	89	90
Overall Study COMPLETED	65	76
Overall Study NOT COMPLETED	24	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline for Nicotine Dependence Among Those With HIV/AIDS

Baseline characteristics by cohort

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling	Total n=179 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 10.1 • n=5 Participants	48.5 years STANDARD_DEVIATION 9.7 • n=7 Participants	48.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	32 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	58 Participants n=7 Participants	122 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants	81 Participants n=7 Participants	164 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	0 Participants n=7 Participants	0 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	71 Participants n=5 Participants	72 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	90 participants n=7 Participants	179 participants n=5 Participants
Time to First Cigarette (TTFC) Within 5 minutes	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Time to First Cigarette (TTFC) 6-30 minutes	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
Time to First Cigarette (TTFC) 31-60 minutes	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Time to First Cigarette (TTFC) More than 60 minutes	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Cigarettes/Day in Past 7 Days	11.2 Cigarettes STANDARD_DEVIATION 6.6 • n=5 Participants	11.8 Cigarettes STANDARD_DEVIATION 9 • n=7 Participants	11.5 Cigarettes STANDARD_DEVIATION 7.9 • n=5 Participants
Breath CO	15 ppm STANDARD_DEVIATION 10.4 • n=5 Participants	13.1 ppm STANDARD_DEVIATION 7.9 • n=7 Participants	14.1 ppm STANDARD_DEVIATION 9.2 • n=5 Participants
Number of Years Smoking	31.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	31.1 years STANDARD_DEVIATION 11 • n=7 Participants	31.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Number of Times Quit Smoking for>24 Hours	8.8 number of times quit smoking STANDARD_DEVIATION 52.9 • n=5 Participants	4.9 number of times quit smoking STANDARD_DEVIATION 12.3 • n=7 Participants	6.9 number of times quit smoking STANDARD_DEVIATION 38.2 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Point Prevalence Tobacco Abstinence	25 Participants	11 Participants

PRIMARY outcome

Timeframe: Week 24

7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Point Prevalence Tobacco Abstinence	13 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 12

The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Quality of Life at Week 12	26.83 score on a scale Standard Deviation 4.49	25.95 score on a scale Standard Deviation 4.01

SECONDARY outcome

Timeframe: Weeks 12

No smoking between the quit day and the follow-up (week 12).

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Continuous Abstinence to Week 12	21 Participants	9 Participants

SECONDARY outcome

Timeframe: Weeks 24

No smoking between the quit day and the follow-up (Week 24).

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Continuous Abstinence to Week 24	9 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 24

days to smoking regularly for 7 days

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Time to 7-day Relapse	58.86 days Standard Deviation 73.90	32.48 days Standard Deviation 62.34

SECONDARY outcome

Timeframe: Week 18

7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.

Outcome measures

Measure	Varenicline n=89 Participants 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 Participants 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Point Prevalence Tobacco Abstinence	19 Participants	10 Participants

Adverse Events

Varenicline

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 28 other events

Deaths: 1 deaths

Serious adverse events

Measure	Varenicline n=89 participants at risk 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 participants at risk 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
General disorders Death	0.00% 0/89 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	1.1% 1/90 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer metastasis	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	0.00% 0/90 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer diagnosis	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	1.1% 1/90 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
Psychiatric disorders Suicidality	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	1.1% 1/90 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Hospitalization	5.6% 5/89 • Number of events 5 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	3.3% 3/90 • Number of events 3 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.

Other adverse events

Measure	Varenicline n=89 participants at risk 12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Varenicline Smoking Cessation Counseling	Placebo n=90 participants at risk 12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Placebo Smoking Cessation Counseling
Gastrointestinal disorders Abdominal pain	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	1.1% 1/90 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Dizziness	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	0.00% 0/90 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
Skin and subcutaneous tissue disorders Skin redness	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	1.1% 1/90 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Weakness	1.1% 1/89 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	0.00% 0/90 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders ER visit	0.00% 0/89 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	2.2% 2/90 • Number of events 2 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Headache	3.4% 3/89 • Number of events 3 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	1.1% 1/90 • Number of events 1 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Irritability	0.00% 0/89 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	2.2% 2/90 • Number of events 2 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Hostility	2.2% 2/89 • Number of events 2 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	5.6% 5/90 • Number of events 5 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
General disorders Agitation	9.0% 8/89 • Number of events 8 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	17.8% 16/90 • Number of events 16 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
Psychiatric disorders Depression	7.9% 7/89 • Number of events 7 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	17.8% 16/90 • Number of events 16 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.
Skin and subcutaneous tissue disorders Skin swelling	21.3% 19/89 • Number of events 19 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.	31.1% 28/90 • Number of events 28 • 27 weeks Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.

Additional Information

Dr. Robert Schnoll

University of Pennsylvania

Phone: 215-746-7143

Email: schnoll@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place