Trial Outcomes & Findings for Varenicline Light Smoking Pilot (NCT NCT04089982)
NCT ID: NCT04089982
Last Updated: 2021-05-11
Results Overview
Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.
COMPLETED
PHASE4
11 participants
Baseline, Visit 4 (week 6)
2021-05-11
Participant Flow
Participant milestones
| Measure |
Varenicline
Varenicline BID
Varenicline: Chantix
|
Placebo
Placebo oral tablet: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varenicline Light Smoking Pilot
Baseline characteristics by cohort
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 4 (week 6)Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.
Outcome measures
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
|---|---|---|
|
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
Baseline
|
6.31 score on a scale
Standard Deviation 2.80
|
4.2 score on a scale
Standard Deviation 1.8
|
|
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
Week 6
|
2.56 score on a scale
Standard Deviation 2.11
|
2.4 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (week 6)Craving level in "real world" situations was assessed through electronic momentary assessment (EMA). Participants were instructed to send a text to the study team each time they experienced craving to smoke a cigarette. Self-report craving level to smoke was reported on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving.
Outcome measures
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
|---|---|---|
|
Change in Self-Reported Craving Level Via Real-World Cue Reactivity
Baseline
|
7.15 score on a scale
Standard Deviation 1.1
|
6.7 score on a scale
Standard Deviation 1.8
|
|
Change in Self-Reported Craving Level Via Real-World Cue Reactivity
Week 6
|
5.5 score on a scale
Standard Deviation 0.5
|
8 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Screening visit, Visit 4 (week 6)7-day point prevalence smoking abstinence. This will be measured through self-reported daily smoking diaries and daily text messaging.
Outcome measures
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
|---|---|---|
|
Changes in Smoking
Baseline
|
3.6 cigarettes per day
Standard Deviation 3.4
|
5.2 cigarettes per day
Standard Deviation 2.3
|
|
Changes in Smoking
Week 6
|
0.5 cigarettes per day
Standard Deviation 0.8
|
2.6 cigarettes per day
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Screening visit, Visit 4 (week 6)Medication adherence is measured by composite self-reported diaries and daily text messaging responses.
Outcome measures
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
|---|---|---|
|
Medication Adherence
|
91.6 Percent medication adherence
Standard Deviation 0.08
|
90.3 Percent medication adherence
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Up to 12 weeksSelf-reported side effects (open ended survey questions) with a ranking scale of 1-2 (mild), 3-5 (moderate), and 6-7 (severe). Any side effect 3 or greater will be reviewed by a study medical provider.
Outcome measures
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
|---|---|---|
|
Medication Tolerance by Self-Reported Side Effects
Abnormal/Vivid Dreams
|
1 Participants
|
2 Participants
|
|
Medication Tolerance by Self-Reported Side Effects
Nausea/Vomiting
|
1 Participants
|
1 Participants
|
|
Medication Tolerance by Self-Reported Side Effects
Constipation
|
1 Participants
|
0 Participants
|
|
Medication Tolerance by Self-Reported Side Effects
Dizziness/Lightheadedness
|
1 Participants
|
0 Participants
|
|
Medication Tolerance by Self-Reported Side Effects
Dry Mouth
|
1 Participants
|
0 Participants
|
|
Medication Tolerance by Self-Reported Side Effects
Fatigue
|
0 Participants
|
2 Participants
|
|
Medication Tolerance by Self-Reported Side Effects
Insomnia/Trouble Sleeping
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening visit, Visit 4 (week 6)7-day point prevalence smoking abstinence confirmed by CO \<7ppm. This will be measured through biochemical confirmation (CO breath test).
Outcome measures
| Measure |
Varenicline
n=6 Participants
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 Participants
Placebo oral tablet: Placebo
|
|---|---|---|
|
Changes in Smoking Abstinence
Baseline
|
9.5 ppm
Standard Deviation 11.1
|
10.2 ppm
Standard Deviation 3.7
|
|
Changes in Smoking Abstinence
Week 6
|
2.6 ppm
Standard Deviation 1.5
|
7.8 ppm
Standard Deviation 5.5
|
Adverse Events
Varenicline
Placebo
Serious adverse events
| Measure |
Varenicline
n=6 participants at risk
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 participants at risk
Placebo oral tablet: Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma flare
|
16.7%
1/6 • Up to 12 weeks
|
0.00%
0/5 • Up to 12 weeks
|
Other adverse events
| Measure |
Varenicline
n=6 participants at risk
Varenicline BID
Varenicline: Chantix
|
Placebo
n=5 participants at risk
Placebo oral tablet: Placebo
|
|---|---|---|
|
Psychiatric disorders
Abnormal/Vivid Dreams
|
16.7%
1/6 • Up to 12 weeks
|
40.0%
2/5 • Up to 12 weeks
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
16.7%
1/6 • Up to 12 weeks
|
20.0%
1/5 • Up to 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 12 weeks
|
0.00%
0/5 • Up to 12 weeks
|
|
General disorders
Dizziness/Lightheadedness
|
16.7%
1/6 • Up to 12 weeks
|
0.00%
0/5 • Up to 12 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
1/6 • Up to 12 weeks
|
0.00%
0/5 • Up to 12 weeks
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 12 weeks
|
40.0%
2/5 • Up to 12 weeks
|
|
General disorders
Insomnia/Trouble Sleeping
|
0.00%
0/6 • Up to 12 weeks
|
20.0%
1/5 • Up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place