Trial Outcomes & Findings for Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation (NCT NCT02859142)

NCT ID: NCT02859142

Last Updated: 2021-09-27

Results Overview

Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

122 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-09-27

Participant Flow

Participant milestones

Participant milestones
Measure
Augmented Treatment
Participants received 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits. Drug: Chantix (Varenicline) Administered according to FDA approved package insert directions Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
Standard Treatment
Participants received 12 weeks of Placebo along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits. Drug: Placebo (identical to Varenicline) Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
Overall Study
STARTED
61
61
Overall Study
COMPLETED
57
52
Overall Study
NOT COMPLETED
4
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Augmented Treatment
Participants received 12 weeks of Chantix along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits. Drug: Chantix (Varenicline) Administered according to FDA approved package insert directions Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
Standard Treatment
Participants received 12 weeks of Placebo along with standard smoking cessation treatment of nicotine patches and behavioral counseling visits. Drug: Placebo (identical to Varenicline) Drug: NicodermCQ (Nicotine Patches) Administered according to FDA approved package insert directions for 10 weeks Behavioral: Counseling Sessions Participants attended one-on-one behavioral counseling sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\]. Behavioral sessions involved teaching behavioral skills to assist with smoking cessation, preventing relapse, and coping with physical or emotional changes associated with cravings.
Overall Study
Adverse Event
1
2
Overall Study
Lost to Follow-up
1
4
Overall Study
Withdrawal by Subject
2
0
Overall Study
Scheduling difficulties
0
3

Baseline Characteristics

One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Augmented Treatment
n=61 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=61 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Total
n=122 Participants
Total of all reporting groups
Age, Continuous
44.0 years
STANDARD_DEVIATION 12.89 • n=61 Participants
44.02 years
STANDARD_DEVIATION 12.04 • n=61 Participants
44 years
STANDARD_DEVIATION 12.43 • n=122 Participants
Sex: Female, Male
Female
26 Participants
n=61 Participants
29 Participants
n=61 Participants
55 Participants
n=122 Participants
Sex: Female, Male
Male
35 Participants
n=61 Participants
32 Participants
n=61 Participants
67 Participants
n=122 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=61 Participants
2 Participants
n=61 Participants
8 Participants
n=122 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
55 Participants
n=61 Participants
59 Participants
n=61 Participants
114 Participants
n=122 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=61 Participants
0 Participants
n=61 Participants
0 Participants
n=122 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=61 Participants
0 Participants
n=61 Participants
1 Participants
n=122 Participants
Race (NIH/OMB)
Asian
1 Participants
n=61 Participants
1 Participants
n=61 Participants
2 Participants
n=122 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=61 Participants
0 Participants
n=61 Participants
0 Participants
n=122 Participants
Race (NIH/OMB)
Black or African American
24 Participants
n=61 Participants
30 Participants
n=61 Participants
54 Participants
n=122 Participants
Race (NIH/OMB)
White
28 Participants
n=61 Participants
28 Participants
n=61 Participants
56 Participants
n=122 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=61 Participants
2 Participants
n=61 Participants
9 Participants
n=122 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=61 Participants
0 Participants
n=61 Participants
0 Participants
n=122 Participants
Region of Enrollment
United States
61 participants
n=61 Participants
61 participants
n=61 Participants
122 participants
n=122 Participants
Duration of smoking in years
25.5 years
STANDARD_DEVIATION 13.90 • n=61 Participants
24.9 years
STANDARD_DEVIATION 12.62 • n=61 Participants
25.2 years
STANDARD_DEVIATION 13.22 • n=122 Participants
Smoking days past month
27.84 days
STANDARD_DEVIATION 0.82 • n=61 Participants
27.41 days
STANDARD_DEVIATION 1.68 • n=61 Participants
27.6 days
STANDARD_DEVIATION 1.33 • n=122 Participants
Cigarettes per smoking day
11.84 cigarettes
STANDARD_DEVIATION 6.26 • n=61 Participants
11.66 cigarettes
STANDARD_DEVIATION 7.06 • n=61 Participants
11.75 cigarettes
STANDARD_DEVIATION 6.65 • n=122 Participants
Fagerström Test for Cigarette Dependence score
4.18 units on a scale
STANDARD_DEVIATION 2.36 • n=61 Participants
3.64 units on a scale
STANDARD_DEVIATION 2.42 • n=61 Participants
3.91 units on a scale
STANDARD_DEVIATION 2.40 • n=122 Participants
Expired carbon monoxide (CO)
16.67 ppm
STANDARD_DEVIATION 11.32 • n=61 Participants
17.54 ppm
STANDARD_DEVIATION 9.68 • n=61 Participants
17.11 ppm
STANDARD_DEVIATION 10.50 • n=122 Participants
Alcohol drinking days
17.54 days
STANDARD_DEVIATION 7.07 • n=61 Participants
18.90 days
STANDARD_DEVIATION 7.33 • n=61 Participants
18.22 days
STANDARD_DEVIATION 7.20 • n=122 Participants
Drinks per drinking day past month
5.41 drinks
STANDARD_DEVIATION 3.73 • n=61 Participants
6.08 drinks
STANDARD_DEVIATION 4.17 • n=61 Participants
5.75 drinks
STANDARD_DEVIATION 3.95 • n=122 Participants
Heavy drinking days past month
8.28 days
STANDARD_DEVIATION 5.99 • n=61 Participants
10.36 days
STANDARD_DEVIATION 8.77 • n=61 Participants
9.32 days
STANDARD_DEVIATION 7.55 • n=122 Participants
DSM5 Alcohol use disorder severity
None (0-1 symptoms)
24 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
28 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
52 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
DSM5 Alcohol use disorder severity
Mild (2-3 symptoms)
16 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
16 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
32 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
DSM5 Alcohol use disorder severity
Moderate (4-5 symptoms)
14 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
9 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
23 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
DSM5 Alcohol use disorder severity
Severe (6+ symptoms)
6 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
7 Participants
n=60 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.
13 Participants
n=120 Participants • One participant from the Augmented Treatment group and one participant from the Standard Treatment group were missing DSM-5 AUD diagnosis data.

PRIMARY outcome

Timeframe: 12 weeks

Number of participants reporting smoking abstinence at 12 weeks from baseline (smoking quit date) via subjective and biologically verified reports.

Outcome measures

Outcome measures
Measure
Augmented Treatment
n=61 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=61 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Change From Baseline Smoking Abstinence Rates at 12 Weeks
27 Participants
17 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Study dropouts (i.e. lost to follow-up or voluntary withdrawals, N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.

Self-reported alcohol drinking days obtained via a past month Timeline Followback Calendar at 12 weeks

Outcome measures

Outcome measures
Measure
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Change From Baseline in Self-Reported Alcohol Drinking Days at 12 Weeks
12.25 days
Standard Deviation 9.54
11.96 days
Standard Deviation 8.90

SECONDARY outcome

Timeframe: 26 weeks

Population: Study dropouts (i.e. lost to follow-up or voluntary withdrawals, N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.

Self reported monthly alcohol drinking days obtained via a past month Timeline Followback Calendar at 26 weeks

Outcome measures

Outcome measures
Measure
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Change From Baseline in Self-Reported Alcohol Drinking Days at 26 Weeks
12.73 days
Standard Deviation 9.06
11.44 days
Standard Deviation 7.91

SECONDARY outcome

Timeframe: 12 weeks

Population: Study dropouts (N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.

Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 12 weeks

Outcome measures

Outcome measures
Measure
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Change From Baseline in Self-Reported Heavy Drinking Days at 12 Weeks
5.02 days
Standard Deviation 7.44
5.58 days
Standard Deviation 7.54

SECONDARY outcome

Timeframe: 26 weeks

Population: Study dropouts (i.e. lost to follow-up or voluntary withdrawals, N=13; 4 in augmented treatment and 9 in standard treatment groups) not include in means reported as drinking quantity and frequency are unknown.

Self reported heavy drinking (5+ drinks/day for men, 4+ drinks/day for women) days obtained via a past month Timeline Followback Calendar at 26 weeks

Outcome measures

Outcome measures
Measure
Augmented Treatment
n=57 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=52 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Change From Baseline in Self-Reported Heavy Drinking Days at 26 Weeks
4.79 days
Standard Deviation 5.33
5.56 days
Standard Deviation 5.91

SECONDARY outcome

Timeframe: 26 weeks

Number of participants reporting smoking abstinence at 26 weeks from quit date via subjective and biologically verified reports.

Outcome measures

Outcome measures
Measure
Augmented Treatment
n=61 Participants
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=61 Participants
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Change From Baseline Smoking Abstinence Rates at 26 Weeks
15 Participants
16 Participants

Adverse Events

Augmented Treatment

Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths

Standard Treatment

Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Augmented Treatment
n=61 participants at risk
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=61 participants at risk
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Psychiatric disorders
Self-injurious thoughts
1.6%
1/61 • Number of events 1 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
0.00%
0/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Nervous system disorders
Syncope
1.6%
1/61 • Number of events 1 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
0.00%
0/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.

Other adverse events

Other adverse events
Measure
Augmented Treatment
n=61 participants at risk
12 weeks of active varenicline + 10 weeks of nicotine patches + behavioral counseling Chantix (Varenicline): Administered according to FDA approved package insert directions NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Standard Treatment
n=61 participants at risk
12 weeks of placebo + 10 weeks of nicotine patches + behavioral counseling Placebo (identical to Varenicline) NicodermCQ (Nicotine Patches): Administered according to FDA approved package insert directions Behavioral: Counseling Sessions with a trained therapist at the first 2 study visits \[pre-quit day (medication initiation date, study week -1) and quit day (study week 0)\].
Gastrointestinal disorders
Nausea
55.7%
34/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
29.5%
18/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Gastrointestinal disorders
Vomiting
14.8%
9/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
4.9%
3/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Gastrointestinal disorders
Gas/flatulence
49.2%
30/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
27.9%
17/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Psychiatric disorders
Abnormal dreams
73.8%
45/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
49.2%
30/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Psychiatric disorders
Sleep problems
50.8%
31/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
24.6%
15/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Cardiac disorders
Increased heart rate
16.4%
10/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
9.8%
6/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Psychiatric disorders
Increased effects of alcohol
27.9%
17/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Psychiatric disorders
Suicidal thoughts
3.3%
2/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
1.6%
1/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Nervous system disorders
Dizziness
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Nervous system disorders
Headache
42.6%
26/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
23.0%
14/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Musculoskeletal and connective tissue disorders
Joint pain
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
23.0%
14/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
Skin and subcutaneous tissue disorders
Skin irritation
19.7%
12/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
14.8%
9/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
General disorders
Other
8.2%
5/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.
6.6%
4/61 • Adverse events were assessed at each study visit (4 visits) over a 12 week period during active treatment.

Additional Information

Andrea King, Ph.D.

University of Chicago

Phone: 7737026181

Results disclosure agreements

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