Trial Outcomes & Findings for Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients (NCT NCT01378858)
NCT ID: NCT01378858
Last Updated: 2021-03-11
Results Overview
Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
Varenicline Treatment as Usual (TAU)
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Varenicline Treatment as Usual (TAU)
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
Baseline Characteristics
Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients
Baseline characteristics by cohort
| Measure |
Varenicline Treatment as Usual (TAU)
n=50 Participants
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
n=50 Participants
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=93 Participants
|
49 years
n=4 Participants
|
49 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Mutliracial/multiethnic
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Cigarettes smoked per day
|
10 cigarettes smoked per day
n=93 Participants
|
12 cigarettes smoked per day
n=4 Participants
|
10 cigarettes smoked per day
n=27 Participants
|
|
Expired carbon monoxide
|
7 parts per million
n=93 Participants
|
8 parts per million
n=4 Participants
|
7 parts per million
n=27 Participants
|
|
Fagerstrom Test of Nicotine Dependence score
|
5 units on a scale
n=93 Participants
|
5 units on a scale
n=4 Participants
|
5 units on a scale
n=27 Participants
|
|
Ladder of change score
|
8 units on a scale
n=93 Participants
|
8 units on a scale
n=4 Participants
|
8 units on a scale
n=27 Participants
|
|
Quit importance
|
10 units on a scale
n=93 Participants
|
10 units on a scale
n=4 Participants
|
10 units on a scale
n=27 Participants
|
|
Quit confidence
|
7 units on a scale
n=93 Participants
|
8 units on a scale
n=4 Participants
|
8 units on a scale
n=27 Participants
|
|
Any past quit attempts
|
39 participants
n=93 Participants
|
42 participants
n=4 Participants
|
81 participants
n=27 Participants
|
|
Preferred brand of cigarettes menthol
|
46 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Number of participants with unstable housing
|
27 participants
n=93 Participants
|
37 participants
n=4 Participants
|
64 participants
n=27 Participants
|
|
Number of participants currently employed
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Number of participants married or living with a partner
|
19 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Lifetime major depressive episode
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Lifetime psychotic disorder
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Lifetime suicide attempt
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Severe global psychiatric symptoms
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Currently receiving psychiatric treatment
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Participants with COPD/Asthma
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Participants with HIV/AIDS
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Median duration methadone maintenance
|
5 years
n=93 Participants
|
5.6 years
n=4 Participants
|
5.6 years
n=27 Participants
|
|
Median methadone dose
|
92 mg
n=93 Participants
|
83.5 mg
n=4 Participants
|
90 mg
n=27 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12Population: Comparison of varenicline TAU and DOT groups
Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure
Outcome measures
| Measure |
Varenicline Treatment as Usual (TAU)
n=50 Participants
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
n=50 Participants
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
Varenicline Adherence as Measured by Pill Count
|
61.8 percentage pills taken/pills dispensed
Interval 55.0 to 68.6
|
78.5 percentage pills taken/pills dispensed
Interval 71.8 to 85.2
|
SECONDARY outcome
Timeframe: Week 12 of treatmentPopulation: intent to treat
Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) \< 8 p.p.m., missing = smoking
Outcome measures
| Measure |
Varenicline Treatment as Usual (TAU)
n=50 Participants
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
n=50 Participants
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Missing = smoking
Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) \< 8 p.p.m.
Outcome measures
| Measure |
Varenicline Treatment as Usual (TAU)
n=50 Participants
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
n=50 Participants
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks
|
6 Participants
|
2 Participants
|
Adverse Events
Varenicline Treatment as Usual (TAU)
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Varenicline Directly Observed Therapy
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline Treatment as Usual (TAU)
n=50 participants at risk
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
n=50 participants at risk
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
Psychiatric disorders
Incident major depressive episode
|
0.00%
0/50 • 12 week intervention period, and 12 week post intervention follow up
|
4.0%
2/50 • Number of events 2 • 12 week intervention period, and 12 week post intervention follow up
|
|
Psychiatric disorders
Incident psychotic disorder
|
2.0%
1/50 • Number of events 1 • 12 week intervention period, and 12 week post intervention follow up
|
0.00%
0/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
1/50 • Number of events 1 • 12 week intervention period, and 12 week post intervention follow up
|
2.0%
1/50 • Number of events 1 • 12 week intervention period, and 12 week post intervention follow up
|
Other adverse events
| Measure |
Varenicline Treatment as Usual (TAU)
n=50 participants at risk
Subjects in the TAU arm will self administer varenicline for 12 weeks.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
Varenicline Directly Observed Therapy
n=50 participants at risk
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
|
|---|---|---|
|
General disorders
Change in taste
|
22.0%
11/50 • 12 week intervention period, and 12 week post intervention follow up
|
30.0%
15/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Dry mouth
|
40.0%
20/50 • 12 week intervention period, and 12 week post intervention follow up
|
48.0%
24/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Change in appetite
|
36.0%
18/50 • 12 week intervention period, and 12 week post intervention follow up
|
38.0%
19/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Nausea
|
38.0%
19/50 • 12 week intervention period, and 12 week post intervention follow up
|
54.0%
27/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Vomiting
|
10.0%
5/50 • 12 week intervention period, and 12 week post intervention follow up
|
26.0%
13/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Gas
|
20.0%
10/50 • 12 week intervention period, and 12 week post intervention follow up
|
34.0%
17/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Constipation
|
32.0%
16/50 • 12 week intervention period, and 12 week post intervention follow up
|
48.0%
24/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Change in concentration
|
8.0%
4/50 • 12 week intervention period, and 12 week post intervention follow up
|
14.0%
7/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Headache
|
24.0%
12/50 • 12 week intervention period, and 12 week post intervention follow up
|
26.0%
13/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Fatigue
|
8.0%
4/50 • 12 week intervention period, and 12 week post intervention follow up
|
24.0%
12/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Insomnia
|
36.0%
18/50 • 12 week intervention period, and 12 week post intervention follow up
|
28.0%
14/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Dizziness
|
10.0%
5/50 • 12 week intervention period, and 12 week post intervention follow up
|
8.0%
4/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Irritability
|
6.0%
3/50 • 12 week intervention period, and 12 week post intervention follow up
|
16.0%
8/50 • 12 week intervention period, and 12 week post intervention follow up
|
|
General disorders
Vivid/more frequent dreams
|
22.0%
11/50 • 12 week intervention period, and 12 week post intervention follow up
|
32.0%
16/50 • 12 week intervention period, and 12 week post intervention follow up
|
Additional Information
Shadi Nahvi, MD, MS
Albert Einstein College of Medicine
Phone: 718 920 5379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place