Trial Outcomes & Findings for Smoking Cessation Treatment for Methadone Maintenance Patients (NCT NCT01027754)
NCT ID: NCT01027754
Last Updated: 2021-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
112 participants
Primary outcome timeframe
Week 12
Results posted on
2021-05-26
Participant Flow
Participant milestones
| Measure |
Varenicline
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
Placebo
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
|
Overall Study
COMPLETED
|
55
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Varenicline
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
Placebo
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
|---|---|---|
|
Overall Study
withdrew/lost to follow-up after interve
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Carbon monoxide, median (IQR) (n=107). The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
Baseline characteristics by cohort
| Measure |
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Customized
|
48 years
STANDARD_DEVIATION 9 • n=57 Participants
|
48 years
STANDARD_DEVIATION 8 • n=55 Participants
|
48 years
STANDARD_DEVIATION 9 • n=112 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=57 Participants
|
28 Participants
n=55 Participants
|
59 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=57 Participants
|
27 Participants
n=55 Participants
|
53 Participants
n=112 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
32 participants
n=57 Participants
|
28 participants
n=55 Participants
|
60 participants
n=112 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 participants
n=57 Participants
|
17 participants
n=55 Participants
|
31 participants
n=112 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
5 participants
n=57 Participants
|
5 participants
n=55 Participants
|
10 participants
n=112 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=57 Participants
|
5 participants
n=55 Participants
|
11 participants
n=112 Participants
|
|
Less than/equal to high school education,
|
41 participants
n=57 Participants
|
46 participants
n=55 Participants
|
87 participants
n=112 Participants
|
|
Married or living with partner
|
23 participants
n=57 Participants
|
31 participants
n=55 Participants
|
54 participants
n=112 Participants
|
|
Employed
|
15 participants
n=57 Participants
|
17 participants
n=55 Participants
|
32 participants
n=112 Participants
|
|
Life-time history of incarceration
|
42 participants
n=57 Participants
|
31 participants
n=55 Participants
|
73 participants
n=112 Participants
|
|
Unstable housing,
|
21 participants
n=57 Participants
|
14 participants
n=55 Participants
|
35 participants
n=112 Participants
|
|
Cigarettes/day, median (IQR)
|
15 cigarettes/day
n=57 Participants
|
15 cigarettes/day
n=55 Participants
|
15 cigarettes/day
n=112 Participants
|
|
Carbon monoxide, median (IQR)
|
10 p.p.m.
n=55 Participants • Carbon monoxide, median (IQR) (n=107). The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
|
9 p.p.m.
n=52 Participants • Carbon monoxide, median (IQR) (n=107). The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
|
10 p.p.m.
n=107 Participants • Carbon monoxide, median (IQR) (n=107). The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
|
|
Carbon monoxide < 8 p.p.m.,
|
22 participants
n=55 Participants • The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
|
18 participants
n=52 Participants • The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
|
40 participants
n=107 Participants • The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112.
|
|
Fagerström Test of Nicotine Dependence score, median (IQR)
|
4 units on a scale
n=57 Participants
|
4 units on a scale
n=55 Participants
|
4 units on a scale
n=112 Participants
|
|
Ladder of change score, median (IQR)
|
7 units on a scale
n=57 Participants
|
7 units on a scale
n=55 Participants
|
7 units on a scale
n=112 Participants
|
|
Quit importance, median (IQR)
|
10 units on a scale
n=57 Participants
|
10 units on a scale
n=55 Participants
|
10 units on a scale
n=112 Participants
|
|
Quit confidence, median (IQR)
|
8 units on a scale
n=57 Participants
|
8 units on a scale
n=55 Participants
|
8 units on a scale
n=112 Participants
|
|
Any past quit attempts, n
|
41 participants
n=57 Participants
|
41 participants
n=55 Participants
|
82 participants
n=112 Participants
|
|
Median duration longest prior quit attempt, weeks (IQR)
|
9 weeks
n=41 Participants • n=82 participants who reported any past quit attempts queried
|
4 weeks
n=41 Participants • n=82 participants who reported any past quit attempts queried
|
4.3 weeks
n=82 Participants • n=82 participants who reported any past quit attempts queried
|
|
Any other household smoker
|
34 participants
n=57 Participants
|
29 participants
n=55 Participants
|
63 participants
n=112 Participants
|
|
Life-time major depressive disorder
|
12 participants
n=57 Participants
|
11 participants
n=55 Participants
|
23 participants
n=112 Participants
|
|
Life-time psychotic disorder, n
|
9 participants
n=57 Participants
|
9 participants
n=55 Participants
|
18 participants
n=112 Participants
|
|
Life-time suicide attempt, n
|
9 participants
n=57 Participants
|
7 participants
n=55 Participants
|
16 participants
n=112 Participants
|
|
Severe global psychiatric symptoms, n
|
9 participants
n=57 Participants
|
12 participants
n=55 Participants
|
21 participants
n=112 Participants
|
|
Currently receiving psychiatric treatment, n
|
24 participants
n=57 Participants
|
26 participants
n=55 Participants
|
50 participants
n=112 Participants
|
|
Hypertension, n
|
19 participants
n=57 Participants
|
22 participants
n=55 Participants
|
41 participants
n=112 Participants
|
|
Diabetes, n
|
13 participants
n=57 Participants
|
11 participants
n=55 Participants
|
24 participants
n=112 Participants
|
|
COPD/asthma, n
|
19 participants
n=57 Participants
|
12 participants
n=55 Participants
|
31 participants
n=112 Participants
|
|
HIV/AIDS, n
|
11 participants
n=57 Participants
|
10 participants
n=55 Participants
|
21 participants
n=112 Participants
|
|
Median duration methadone maintenance, years (IQR)
|
4 years
n=57 Participants
|
7 years
n=55 Participants
|
5.9 years
n=112 Participants
|
|
Median methadone dose, mg (IQR)
|
110 milligram
n=57 Participants
|
100 milligram
n=55 Participants
|
110 milligram
n=112 Participants
|
|
Self reported use of heroin in 30 days prior to baseline, n
|
8 participants
n=57 Participants
|
5 participants
n=55 Participants
|
13 participants
n=112 Participants
|
|
Self reported use of other opiates in 30 days prior to baseline, n
|
11 participants
n=57 Participants
|
13 participants
n=55 Participants
|
24 participants
n=112 Participants
|
|
Self reported use of cocaine (including crack) in 30 days prior to baseline, n
|
17 participants
n=57 Participants
|
8 participants
n=55 Participants
|
25 participants
n=112 Participants
|
|
Self reported use of marijuana in 30 days prior to baseline, n
|
14 participants
n=57 Participants
|
13 participants
n=55 Participants
|
27 participants
n=112 Participants
|
|
Self reported use of hazardous alcohol use in 30 days prior to baseline, n
|
4 participants
n=57 Participants
|
9 participants
n=55 Participants
|
13 participants
n=112 Participants
|
|
Participants enrolled at clinical site 1, n
|
9 participants
n=57 Participants
|
7 participants
n=55 Participants
|
16 participants
n=112 Participants
|
|
Participants enrolled at clinical site 2, n
|
32 participants
n=57 Participants
|
33 participants
n=55 Participants
|
65 participants
n=112 Participants
|
|
Participants enrolled at clinical site 3, n
|
16 participants
n=57 Participants
|
15 participants
n=55 Participants
|
31 participants
n=112 Participants
|
PRIMARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
|
0 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Week 24Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: End of 12 week intervention periodParticipants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.
Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Counseling Visits Completed
|
1.85 visits completed
Standard Deviation 1.65
|
1.96 visits completed
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: 24 weeksMean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.
Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Study Visits Completed
|
5.36 visits completed
Standard Deviation 1.38
|
5.72 visits completed
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 24Population: Because of the high rate of missing data (6 of 51 cases of self-reported abstinence not verified by cotinine), and because the semi-quantitative assay we used (Nymox NicAlert™) did not use a ≤ 15 ng/ml threshold (10 of 51 cases fell in the 10-30 ng/ml range), this data was not analyzed.
Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 24Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day
At week 2
|
6 cigarettes/day
Interval 3.0 to 10.0
|
3 cigarettes/day
Interval 1.0 to 9.0
|
|
Number of Cigarettes Smoked Per Day
At week 4
|
5 cigarettes/day
Interval 3.0 to 10.0
|
2 cigarettes/day
Interval 0.5 to 7.0
|
|
Number of Cigarettes Smoked Per Day
At week 8
|
5 cigarettes/day
Interval 3.0 to 10.0
|
3 cigarettes/day
Interval 1.0 to 6.0
|
|
Number of Cigarettes Smoked Per Day
At week 12
|
5 cigarettes/day
Interval 2.0 to 10.0
|
2 cigarettes/day
Interval 0.5 to 2.0
|
|
Number of Cigarettes Smoked Per Day
At week 24
|
5 cigarettes/day
Interval 2.5 to 10.0
|
4 cigarettes/day
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 24Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
At week 2
|
25 participants
|
33 participants
|
|
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
At week 4
|
27 participants
|
35 participants
|
|
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
At week 8
|
32 participants
|
37 participants
|
|
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
At week 12
|
25 participants
|
37 participants
|
|
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
At week 24
|
30 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 24Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).
Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Confidence in Quitting Smoking (1-10 Scale)
At week 2
|
8 units on a scale
Interval 6.0 to 10.0
|
8 units on a scale
Interval 7.0 to 10.0
|
|
Confidence in Quitting Smoking (1-10 Scale)
At week 4
|
8 units on a scale
Interval 7.0 to 10.0
|
9 units on a scale
Interval 6.0 to 10.0
|
|
Confidence in Quitting Smoking (1-10 Scale)
At week 8
|
9 units on a scale
Interval 7.0 to 10.0
|
9 units on a scale
Interval 7.0 to 10.0
|
|
Confidence in Quitting Smoking (1-10 Scale)
At week 12
|
8 units on a scale
Interval 6.0 to 10.0
|
9 units on a scale
Interval 7.0 to 10.0
|
|
Confidence in Quitting Smoking (1-10 Scale)
At week 24
|
8 units on a scale
Interval 5.0 to 10.0
|
8 units on a scale
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, and 24Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).
Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Importance of Quitting Smoking (1-10 Scale)
At week 2
|
10 units on a scale
Interval 9.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
|
Importance of Quitting Smoking (1-10 Scale)
At week 4
|
10 units on a scale
Interval 9.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
|
Importance of Quitting Smoking (1-10 Scale)
At week 8
|
10 units on a scale
Interval 9.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
|
Importance of Quitting Smoking (1-10 Scale)
At week 12
|
10 units on a scale
Interval 9.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
|
Importance of Quitting Smoking (1-10 Scale)
At week 24
|
10 units on a scale
Interval 8.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Adverse Medication Effects
Nausea
|
14 participants
|
29 participants
|
|
Adverse Medication Effects
Change in taste
|
14 participants
|
18 participants
|
|
Adverse Medication Effects
Dry Mouth
|
23 participants
|
27 participants
|
|
Adverse Medication Effects
Change in appetite
|
18 participants
|
29 participants
|
|
Adverse Medication Effects
Vomiting
|
8 participants
|
11 participants
|
|
Adverse Medication Effects
Gas
|
15 participants
|
19 participants
|
|
Adverse Medication Effects
Constipation
|
9 participants
|
23 participants
|
|
Adverse Medication Effects
Change in concentration
|
6 participants
|
6 participants
|
|
Adverse Medication Effects
Headache
|
18 participants
|
11 participants
|
|
Adverse Medication Effects
Fatigue
|
13 participants
|
15 participants
|
|
Adverse Medication Effects
Insomnia
|
13 participants
|
15 participants
|
|
Adverse Medication Effects
Dizziness
|
8 participants
|
9 participants
|
|
Adverse Medication Effects
Irritability
|
8 participants
|
10 participants
|
|
Adverse Medication Effects
Vivid/more frequent dreams
|
22 participants
|
18 participants
|
SECONDARY outcome
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Week 2
|
11 participants
|
9 participants
|
|
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Week 4
|
7 participants
|
4 participants
|
|
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Week 8
|
7 participants
|
6 participants
|
|
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Week 12
|
5 participants
|
8 participants
|
|
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Week 24
|
5 participants
|
5 participants
|
SECONDARY outcome
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Week 2
|
1 participants
|
1 participants
|
|
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Week 4
|
0 participants
|
1 participants
|
|
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Week 8
|
1 participants
|
1 participants
|
|
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Week 12
|
2 participants
|
1 participants
|
|
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Week 24
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 4
|
0 participants
|
0 participants
|
|
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 2
|
0 participants
|
0 participants
|
|
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 8
|
0 participants
|
2 participants
|
|
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 12
|
1 participants
|
0 participants
|
|
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 24
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 2
|
0 participants
|
0 participants
|
|
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 4
|
0 participants
|
0 participants
|
|
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 8
|
0 participants
|
0 participants
|
|
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 12
|
0 participants
|
0 participants
|
|
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Week 24
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)Outcome measures
| Measure |
Placebo
n=55 Participants
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
Varenicline
n=57 Participants
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
|---|---|---|
|
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Week 2
|
2 participants
|
0 participants
|
|
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Week 4
|
0 participants
|
0 participants
|
|
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Week 8
|
0 participants
|
1 participants
|
|
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Week 12
|
1 participants
|
1 participants
|
|
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Week 24
|
1 participants
|
2 participants
|
Adverse Events
Varenicline
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=57 participants at risk
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
Placebo
n=55 participants at risk
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
|---|---|---|
|
Endocrine disorders
Hypoglycemic episode preceding increase in long-acting insulin dose
|
1.8%
1/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
0.00%
0/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Endocrine disorders
Hospitalization for alcohol and cocaine rehabilitation
|
1.8%
1/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
0.00%
0/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Musculoskeletal and connective tissue disorders
Knee replacement following mechanical fall
|
1.8%
1/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
0.00%
0/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Cardiac disorders
Hospitalization for chest pain
|
0.00%
0/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
1.8%
1/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Endocrine disorders
Hospitalization for alcohol detoxification
|
0.00%
0/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
1.8%
1/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
Other adverse events
| Measure |
Varenicline
n=57 participants at risk
Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
|
Placebo
n=55 participants at risk
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
|
|---|---|---|
|
Psychiatric disorders
Psychiatric outcome: incident major depressive episode
|
3.5%
2/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
1.8%
1/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Psychiatric disorders
Psychiatric outcome: incident manic episode
|
0.00%
0/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
0.00%
0/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Psychiatric disorders
Psychiatric outcome: Incident psychotic disorder
|
1.8%
1/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
5.5%
3/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Psychiatric disorders
Psychiatric outcome: suicidal ideation
|
5.3%
3/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
7.3%
4/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Psychiatric disorders
Psychiatric outcome: severe global psychiatric symptoms
|
21.1%
12/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
30.9%
17/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Respiratory, thoracic and mediastinal disorders
Medical symptom: change in taste
|
31.6%
18/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
25.5%
14/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
General disorders
medical symptom: dry mouth
|
47.4%
27/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
41.8%
23/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Metabolism and nutrition disorders
medical symptom: change in appetite
|
50.9%
29/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
32.7%
18/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Gastrointestinal disorders
medical symptom: nausea
|
50.9%
29/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
25.5%
14/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Gastrointestinal disorders
medical symptom: vomiting
|
19.3%
11/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
14.5%
8/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Gastrointestinal disorders
medical symptom: gas
|
33.3%
19/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
27.3%
15/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Gastrointestinal disorders
medical symptom: constipation
|
40.4%
23/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
16.4%
9/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Nervous system disorders
medical symptom: change in concentration
|
10.5%
6/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
10.9%
6/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Nervous system disorders
Medical Symptom: headache
|
19.3%
11/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
32.7%
18/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
General disorders
medical symptom: fatigue
|
26.3%
15/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
23.6%
13/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Psychiatric disorders
medical symptom: insomnia
|
26.3%
15/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
23.6%
13/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
General disorders
medical symptom: dizziness
|
15.8%
9/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
14.5%
8/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Nervous system disorders
medical symptom: irritability
|
17.5%
10/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
14.5%
8/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
|
Nervous system disorders
medical symptom: vivid/more frequent dreams
|
31.6%
18/57
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
40.0%
22/55
Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
|
Additional Information
Dr. Shadi Nahvi
Albert Einstein College of Medicine/Montefiore Medical Center
Phone: 718 920 5379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place