Trial Outcomes & Findings for Smoking Cessation & Opioid Dependence Treatment Integration (NCT NCT02854800)
NCT ID: NCT02854800
Last Updated: 2020-08-14
Results Overview
For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
74 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2020-08-14
Participant Flow
Participants were recruited from the Comprehensive Outpatient Addiction Treatment (COAT) program at Chestnut Ridge Hospital on the campus of West Virginia University. Participants were recruited from the COAT clinic between 7/8/2016 and 2/2/2017.
All participants that were enrolled (after passing the initial screening and not meeting any of the exclusion criteria) were assigned a group.
Participant milestones
| Measure |
Weekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
14
|
|
Overall Study
COMPLETED
|
12
|
15
|
8
|
|
Overall Study
NOT COMPLETED
|
20
|
13
|
6
|
Reasons for withdrawal
| Measure |
Weekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
16
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
3
|
Baseline Characteristics
Smoking Cessation & Opioid Dependence Treatment Integration
Baseline characteristics by cohort
| Measure |
Weekly Opioid Tx
n=32 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=28 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=14 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.38 years
STANDARD_DEVIATION 6.66 • n=5 Participants
|
32.68 years
STANDARD_DEVIATION 6.61 • n=7 Participants
|
36.71 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
33.67 years
STANDARD_DEVIATION 7.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Expired-air Carbon Monoxide
|
35.72 parts per million (ppm)
STANDARD_DEVIATION 17.40 • n=5 Participants
|
33.69 parts per million (ppm)
STANDARD_DEVIATION 12.43 • n=7 Participants
|
33.14 parts per million (ppm)
STANDARD_DEVIATION 15.20 • n=5 Participants
|
33.92 parts per million (ppm)
STANDARD_DEVIATION 16.21 • n=4 Participants
|
|
Cigarettes Smoked per Day
|
23.09 cigarettes per day
STANDARD_DEVIATION 9.19 • n=5 Participants
|
23.15 cigarettes per day
STANDARD_DEVIATION 8.34 • n=7 Participants
|
27.00 cigarettes per day
STANDARD_DEVIATION 9.27 • n=5 Participants
|
23.31 cigarettes per day
STANDARD_DEVIATION 9.49 • n=4 Participants
|
|
Years Smoking
|
12.72 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
11.23 years
STANDARD_DEVIATION 6.38 • n=7 Participants
|
14.73 years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
12.40 years
STANDARD_DEVIATION 7.89 • n=4 Participants
|
|
Consecutive Days in Opioid Treatment
|
45.65 days
STANDARD_DEVIATION 132.10 • n=5 Participants
|
145.57 days
STANDARD_DEVIATION 97.82 • n=7 Participants
|
702.38 days
STANDARD_DEVIATION 502.62 • n=5 Participants
|
193.08 days
STANDARD_DEVIATION 319.90 • n=4 Participants
|
|
Cigarette Dependence Score
|
6.84 units on a scale
STANDARD_DEVIATION 1.95 • n=5 Participants
|
6.64 units on a scale
STANDARD_DEVIATION 1.91 • n=7 Participants
|
7.43 units on a scale
STANDARD_DEVIATION 1.99 • n=5 Participants
|
6.93 units on a scale
STANDARD_DEVIATION 1.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All participants that completed informed consent were included to calculate rates of assignment to treatment (N=88). This is different from the number of participants enrolled (N=74) because n=14 participants provided informed consent but were then found to be ineligible for the study based on initial questionnaires.
For primary feasibility outcomes, recruitment, assignment to treatment, and retention rates were analyzed using descriptive statistics.
Outcome measures
| Measure |
Weekly Opioid Tx
n=40 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=33 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Recruitment, Assignment to Treatment, and Retention Rates
Recruited and Consented
|
40 Participants
|
33 Participants
|
15 Participants
|
|
Recruitment, Assignment to Treatment, and Retention Rates
Assigned to Treatment
|
32 Participants
|
28 Participants
|
14 Participants
|
|
Recruitment, Assignment to Treatment, and Retention Rates
Completed 4 Weeks
|
20 Participants
|
19 Participants
|
13 Participants
|
|
Recruitment, Assignment to Treatment, and Retention Rates
Completed 8 Weeks
|
12 Participants
|
15 Participants
|
9 Participants
|
|
Recruitment, Assignment to Treatment, and Retention Rates
Completed 12 Weeks
|
12 Participants
|
15 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksPopulation: Participants that completed the entire 12-week study were compared to those that dropped out before completing to determine potential reasons for attrition.
Drug withdrawal and medication side effect ratings were assessed as potential reasons for attrition. This assessment was completed by calculating the mean percentage of days, out of the first four weeks, during which effects were reported by participants who completed the entire 12-week protocol versus participants that dropped out. We limited this analysis to the first four weeks.
Outcome measures
| Measure |
Weekly Opioid Tx
n=39 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=35 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Nausea
|
60.3 percentage of study days
Standard Deviation 38.0
|
43.4 percentage of study days
Standard Deviation 35.4
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Headache
|
47.2 percentage of study days
Standard Deviation 38.4
|
39.8 percentage of study days
Standard Deviation 32.1
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Sleep Problems
|
37.9 percentage of study days
Standard Deviation 37.3
|
46.6 percentage of study days
Standard Deviation 40.0
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Gas/Constipation
|
45.9 percentage of study days
Standard Deviation 40.0
|
48.9 percentage of study days
Standard Deviation 37.3
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Abnormal Dreams
|
42.0 percentage of study days
Standard Deviation 33.7
|
53.7 percentage of study days
Standard Deviation 38.6
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Depressed Mood
|
39.6 percentage of study days
Standard Deviation 39.6
|
49.0 percentage of study days
Standard Deviation 38.0
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Drowsy
|
52.8 percentage of study days
Standard Deviation 36.4
|
50.3 percentage of study days
Standard Deviation 36.4
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Craving
|
86.5 percentage of study days
Standard Deviation 23.2
|
78.1 percentage of study days
Standard Deviation 28.9
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Irritability
|
72.6 percentage of study days
Standard Deviation 35.1
|
70.4 percentage of study days
Standard Deviation 29.8
|
—
|
|
Percentage of Days on Which Participants Experienced Each Reason for Attrition
Restlessness
|
58.7 percentage of study days
Standard Deviation 40.7
|
56.7 percentage of study days
Standard Deviation 37.8
|
—
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: Only data for participants that completed the entire 12-week protocol were analyzed. Data were analyzed as a single group/arm as pre-specified in the protocol. N=2940 study days (84 days per participant) was the unit of analysis.
Medication non-adherence rates: The number of study days on which participants a) self-reported not taking the medication (i.e. provided a response of "no") or b) had a missing medication response (i.e. provided no response) via text message. Text-messaging non-adherence rates: The number of study days in which participants failed to respond to one or more assessments measured via text message.
Outcome measures
| Measure |
Weekly Opioid Tx
n=2940 Study Days
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Number of Study Days With Protocol Non-Adherence
Days with missing text data
|
1105 study days
|
—
|
—
|
|
Number of Study Days With Protocol Non-Adherence
Days of not taking medication
|
40 study days
|
—
|
—
|
|
Number of Study Days With Protocol Non-Adherence
Days of not reporting medication use
|
305 study days
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: Only analyzed data for participants that completed the entire 12-week protocol.
Side effect ratings of nausea, headache, sleep problems, gas/constipation, abnormal dreams, depressed mood, and drowsy; scores ranged from 0-10 and higher scores indicate more severe symptoms.
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Medication Acceptability for Completers
Nausea
|
2.55 points on a scale
Standard Deviation 2.08
|
1.46 points on a scale
Standard Deviation 0.84
|
3.09 points on a scale
Standard Deviation 3.59
|
|
Medication Acceptability for Completers
Headache
|
2.21 points on a scale
Standard Deviation 1.76
|
1.61 points on a scale
Standard Deviation 1.40
|
1.92 points on a scale
Standard Deviation 2.66
|
|
Medication Acceptability for Completers
Sleep Disturbances
|
3.35 points on a scale
Standard Deviation 2.89
|
2.18 points on a scale
Standard Deviation 1.67
|
1.07 points on a scale
Standard Deviation 1.60
|
|
Medication Acceptability for Completers
Gas/Constipation
|
3.41 points on a scale
Standard Deviation 2.65
|
2.30 points on a scale
Standard Deviation 1.98
|
2.48 points on a scale
Standard Deviation 2.47
|
|
Medication Acceptability for Completers
Abnormal Dreams
|
3.42 points on a scale
Standard Deviation 2.61
|
2.94 points on a scale
Standard Deviation 2.16
|
0.82 points on a scale
Standard Deviation 1.03
|
|
Medication Acceptability for Completers
Depressed Mood
|
2.94 points on a scale
Standard Deviation 2.59
|
2.15 points on a scale
Standard Deviation 1.59
|
1.10 points on a scale
Standard Deviation 0.90
|
|
Medication Acceptability for Completers
Drowsy
|
3.40 points on a scale
Standard Deviation 2.56
|
2.05 points on a scale
Standard Deviation 1.65
|
2.36 points on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Only analyzed data for participants that completed the entire 12-week protocol.
A quit attempt was defined as at least one study day on which 0 cigarettes smoked was reported via text message. Actual quit rates were determined by biochemically verified cigarette abstinence, which was an expired air carbon monoxide reading of \< 8 parts per million (ppm).
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit
Quit Attempt Rates
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Cigarette Smoking Quit Attempts and Actual Quit
Quit Rates
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: For this outcome measure, we include only participants that reported at least one study day on which they smoked 0 cigarettes (i.e., made a quit attempt).
A quit attempt was defined as at least one day on which participants reported 0 cigarettes smoked via text message. Reports of \>0 cigarettes on subsequent days was indicative of relapse.
Outcome measures
| Measure |
Weekly Opioid Tx
n=2 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=2 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=2 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Number of Study Days Until First Cigarette Quit Attempt
|
35.5 number of study days
Standard Deviation 24.7
|
11.5 number of study days
Standard Deviation 12.0
|
12.5 number of study days
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Only data for participants that completed the entire 12-week protocol were analyzed.
The number of cigarettes smoked per day were reported via text message by participants daily. These numbers were averaged within weeks to give 12 separate average weekly values for cigarettes per day.
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Cigarettes Smoked Per Day
Week 1
|
18.21 cigarettes per day
Standard Error 2.80
|
15.53 cigarettes per day
Standard Error 1.74
|
16.00 cigarettes per day
Standard Error 2.00
|
|
Cigarettes Smoked Per Day
Week 2
|
14.28 cigarettes per day
Standard Error 2.30
|
12.02 cigarettes per day
Standard Error 1.40
|
11.18 cigarettes per day
Standard Error 2.07
|
|
Cigarettes Smoked Per Day
Week 3
|
11.90 cigarettes per day
Standard Error 2.17
|
10.21 cigarettes per day
Standard Error 1.66
|
8.04 cigarettes per day
Standard Error 2.10
|
|
Cigarettes Smoked Per Day
Week 4
|
9.34 cigarettes per day
Standard Error 1.95
|
9.58 cigarettes per day
Standard Error 1.39
|
8.11 cigarettes per day
Standard Error 2.37
|
|
Cigarettes Smoked Per Day
Week 5
|
9.35 cigarettes per day
Standard Error 2.17
|
9.52 cigarettes per day
Standard Error 1.63
|
7.91 cigarettes per day
Standard Error 2.29
|
|
Cigarettes Smoked Per Day
Week 6
|
9.21 cigarettes per day
Standard Error 1.98
|
9.85 cigarettes per day
Standard Error 1.66
|
6.68 cigarettes per day
Standard Error 2.01
|
|
Cigarettes Smoked Per Day
Week 7
|
9.40 cigarettes per day
Standard Error 2.13
|
9.45 cigarettes per day
Standard Error 1.88
|
7.00 cigarettes per day
Standard Error 2.30
|
|
Cigarettes Smoked Per Day
Week 8
|
8.87 cigarettes per day
Standard Error 1.99
|
9.87 cigarettes per day
Standard Error 1.80
|
7.13 cigarettes per day
Standard Error 2.22
|
|
Cigarettes Smoked Per Day
Week 9
|
7.98 cigarettes per day
Standard Error 1.91
|
9.58 cigarettes per day
Standard Error 1.85
|
6.55 cigarettes per day
Standard Error 2.10
|
|
Cigarettes Smoked Per Day
Week 10
|
8.34 cigarettes per day
Standard Error 2.04
|
9.47 cigarettes per day
Standard Error 1.79
|
6.37 cigarettes per day
Standard Error 2.21
|
|
Cigarettes Smoked Per Day
Week 11
|
7.83 cigarettes per day
Standard Error 2.03
|
10.90 cigarettes per day
Standard Error 2.03
|
6.83 cigarettes per day
Standard Error 2.17
|
|
Cigarettes Smoked Per Day
Week 12
|
7.35 cigarettes per day
Standard Error 2.19
|
10.39 cigarettes per day
Standard Error 1.83
|
5.23 cigarettes per day
Standard Error 1.66
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Only analyzed data for participants that completed the entire 12-week protocol.
Average self-reported ratings for craving, irritability, restless, alert, bored, calm/relaxed, able to focus, nervous, and other; scores ranged from 0-10 and higher scores indicate higher levels of that withdrawal effect
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Drug Withdrawal Ratings
Craving
|
5.03 units on a scale
Standard Deviation 1.85
|
4.55 units on a scale
Standard Deviation 1.73
|
4.16 units on a scale
Standard Deviation 3.19
|
|
Drug Withdrawal Ratings
Irritability
|
4.37 units on a scale
Standard Deviation 1.87
|
3.09 units on a scale
Standard Deviation 1.75
|
2.67 units on a scale
Standard Deviation 2.27
|
|
Drug Withdrawal Ratings
Restless
|
3.67 units on a scale
Standard Deviation 2.36
|
1.97 units on a scale
Standard Deviation 1.49
|
1.87 units on a scale
Standard Deviation 2.05
|
|
Drug Withdrawal Ratings
Alert
|
6.23 units on a scale
Standard Deviation 1.76
|
5.26 units on a scale
Standard Deviation 2.17
|
7.98 units on a scale
Standard Deviation 1.08
|
|
Drug Withdrawal Ratings
Bored
|
2.98 units on a scale
Standard Deviation 1.64
|
1.72 units on a scale
Standard Deviation 1.25
|
1.58 units on a scale
Standard Deviation 1.74
|
|
Drug Withdrawal Ratings
Calm/Relaxed
|
5.12 units on a scale
Standard Deviation 2.40
|
4.74 units on a scale
Standard Deviation 2.29
|
6.75 units on a scale
Standard Deviation 2.18
|
|
Drug Withdrawal Ratings
Able to Focus
|
6.11 units on a scale
Standard Deviation 2.20
|
5.48 units on a scale
Standard Deviation 2.12
|
8.08 units on a scale
Standard Deviation 0.79
|
|
Drug Withdrawal Ratings
Nervous
|
2.93 units on a scale
Standard Deviation 2.81
|
1.96 units on a scale
Standard Deviation 1.65
|
1.62 units on a scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Only data for participants that completed the entire 12-week protocol were analyzed.
Expired air carbon monoxide levels were measured for participants every 4 weeks at their in-person study visits, resulting in 4 separate measures across the 12-week period.
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Expired Air Carbon Monoxide
Baseline
|
46.00 parts per million (ppm)
Standard Deviation 20.75
|
34.27 parts per million (ppm)
Standard Deviation 11.60
|
34.25 parts per million (ppm)
Standard Deviation 13.65
|
|
Expired Air Carbon Monoxide
Week 4
|
34.18 parts per million (ppm)
Standard Deviation 14.86
|
30.00 parts per million (ppm)
Standard Deviation 11.58
|
26.13 parts per million (ppm)
Standard Deviation 18.34
|
|
Expired Air Carbon Monoxide
Week 8
|
37.45 parts per million (ppm)
Standard Deviation 19.93
|
28.60 parts per million (ppm)
Standard Deviation 12.77
|
25.00 parts per million (ppm)
Standard Deviation 17.67
|
|
Expired Air Carbon Monoxide
Week 12
|
34.00 parts per million (ppm)
Standard Deviation 18.42
|
25.27 parts per million (ppm)
Standard Deviation 9.55
|
24.63 parts per million (ppm)
Standard Deviation 15.03
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Only data for participants that completed the entire 12-week protocol were analyzed.
Relapse was determined by semi-quantitative urine testing (positive vs negative result). Positive results for illicit drugs were assessed separately (opioids, cocaine, THC, benzodiazepines, amphetamines, and atypical antipsychotics).
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
THC
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
Benzodiazapines
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
Cocaine
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
Amphetamine
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Relapse for Illicit Drugs (Opioids, Cocaine, THC, Etc)
Atypical antipsychotics
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Only data for participants that completed the entire 12-week protocol were analyzed.
The Readiness to Quit Ladder was administered to participants at each of their in-person study visits, for a total of 4 data collections. Participants were asked to indicate their readiness to quit smoking on a scale ranging from 0 (I have no interest in quitting smoking) to 10 (I have already quit smoking).
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Readiness to Quit Smoking
Baseline
|
6.17 units on a scale
Standard Deviation 0.83
|
5.87 units on a scale
Standard Deviation 1.13
|
5.63 units on a scale
Standard Deviation 1.69
|
|
Readiness to Quit Smoking
Week 4
|
7.50 units on a scale
Standard Deviation 0.80
|
7.20 units on a scale
Standard Deviation 0.86
|
7.88 units on a scale
Standard Deviation 1.25
|
|
Readiness to Quit Smoking
Week 8
|
7.50 units on a scale
Standard Deviation 0.52
|
7.47 units on a scale
Standard Deviation 0.74
|
8.38 units on a scale
Standard Deviation 0.74
|
|
Readiness to Quit Smoking
Week 12
|
8.33 units on a scale
Standard Deviation 1.07
|
7.53 units on a scale
Standard Deviation 0.83
|
8.13 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Only data for participants that completed the entire 12-week protocol were included in analyses.
Participants indicated one of the following stages of change at each of their four in-person study visits: Precontemplation (no plans to quit smoking), Contemplation (plans to quit smoking in the next 6 months), Preparation (plans to quit smoking in the next 30 days), Action (currently engaging in quitting smoking), or Maintenance (quit smoking more than 6 months ago). Data were quantified by determining the number of participants who moved towards quitting (i.e., moved up one or more stages), the number of participants who moved away from quitting (i.e., moved down one or more stages), and and the number of participants who remained in the same stage.
Outcome measures
| Measure |
Weekly Opioid Tx
n=12 Participants
Participants in this group attended an outpatient opioid clinic once per week. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Bi-weekly Opioid Tx
n=15 Participants
Participants in this group attended an outpatient opioid clinic once biweekly. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
Monthly Opioid Tx
n=8 Participants
Participants in this group attended an outpatient opioid clinic once per month. As part of the current study, 12-week dosing of varenicline per label recommendations: 0.5mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84). Pill form/blister pack
|
|---|---|---|---|
|
Number of Participants That Moved in Stage of Change for Quitting Smoking
Moved away from quitting
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants That Moved in Stage of Change for Quitting Smoking
Moved toward quitting
|
7 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants That Moved in Stage of Change for Quitting Smoking
Stayed the same
|
1 Participants
|
8 Participants
|
4 Participants
|
Adverse Events
Weekly Opioid Tx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bi-weekly Opioid Tx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Monthly Opioid Tx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place