Trial Outcomes & Findings for Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients (NCT NCT02147132)
NCT ID: NCT02147132
Last Updated: 2018-12-05
Results Overview
Subjects will be given a special electronic cigarette lighter called Quitbit.The electronic lighter will record a timestamp for each time the lighter is used to light a cigarette. Data will be collected from the lighter at each study visit. This will measure how many cigarettes are smoked and when.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
7 weeks
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Order 1
Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
Order 2
Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
Order 3
Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
Order 4
Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Order 1
Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
Order 2
Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
Order 3
Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
Order 4
Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).
Nicotine Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.
Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Placebo Nasal Spray: 7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Placebo Varenicline: 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=7 Participants
All participants randomized in this crossover trial (each randomized participant was intended to receive each medication)
|
|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · White, Non-Hispanic
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race, Ethnicity · Other, Non-Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Fagerström Test for Nicotine Dependence
|
5.3 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Years in Methadone Treatment
|
3.1 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Current Methadone Dose
|
109.9 milligrams
STANDARD_DEVIATION 35.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.
Subjects will be given a special electronic cigarette lighter called Quitbit.The electronic lighter will record a timestamp for each time the lighter is used to light a cigarette. Data will be collected from the lighter at each study visit. This will measure how many cigarettes are smoked and when.
Outcome measures
| Measure |
Nicotine Nasal Spray
n=7 Participants
All participants who received the nicotine nasal spray
|
Placebo Nasal Spray
n=7 Participants
All participants who received the placebo nasal spray
|
Varenicline Tablets
n=6 Participants
All participants who received the active varenicline tablets
|
Placebo Varenicline Tablets
n=6 Participants
All participants who received the placebo varenicline tablets
|
|---|---|---|---|---|
|
Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose
|
0.294 proportion of daily cigarettes
Standard Deviation 0.130
|
0.177 proportion of daily cigarettes
Standard Deviation 0.104
|
0.196 proportion of daily cigarettes
Standard Deviation 0.088
|
0.325 proportion of daily cigarettes
Standard Deviation 0.346
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.
The Quitbit lighter will measure how many cigarettes are smoked per day. In addition to the Quitbit lighter measurement, the Timeline Follow Back (TLFB) form will be filled out for each subject to measure use, as well.
Outcome measures
| Measure |
Nicotine Nasal Spray
n=7 Participants
All participants who received the nicotine nasal spray
|
Placebo Nasal Spray
n=7 Participants
All participants who received the placebo nasal spray
|
Varenicline Tablets
n=6 Participants
All participants who received the active varenicline tablets
|
Placebo Varenicline Tablets
n=6 Participants
All participants who received the placebo varenicline tablets
|
|---|---|---|---|---|
|
Cigarettes Per Day
|
13.7 cigarettes per day
Standard Deviation 6.4
|
15.8 cigarettes per day
Standard Deviation 8.2
|
12.5 cigarettes per day
Standard Deviation 12.8
|
9.0 cigarettes per day
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.
Carbon monoxide (CO) in each participant's breath will be tested. A CO level less than or equal to 8 parts-per-million will be used to verify reports of no smoking.
Outcome measures
| Measure |
Nicotine Nasal Spray
n=7 Participants
All participants who received the nicotine nasal spray
|
Placebo Nasal Spray
n=7 Participants
All participants who received the placebo nasal spray
|
Varenicline Tablets
n=6 Participants
All participants who received the active varenicline tablets
|
Placebo Varenicline Tablets
n=6 Participants
All participants who received the placebo varenicline tablets
|
|---|---|---|---|---|
|
Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million
Participants with CO less than or equal to 8 ppm
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million
Participants with CO greater than 8 ppm
|
5 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
Adverse Events
Nicotine Nasal Spray
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Nasal Spray
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Varenicline Tablets
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Varenicline Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Nasal Spray
n=7 participants at risk
All participants who received the nicotine nasal spray
|
Placebo Nasal Spray
n=7 participants at risk
All participants who received the placebo nasal spray
|
Varenicline Tablets
n=6 participants at risk
All participants who received the active varenicline tablets
|
Placebo Varenicline Tablets
n=6 participants at risk
All participants who received the placebo varenicline tablets
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/7 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Ear and labyrinth disorders
ear ache
|
0.00%
0/7 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.00%
0/7 • 8 weeks
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Nervous system disorders
headache
|
42.9%
3/7 • Number of events 3 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
flu-like symptoms
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 3 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
14.3%
1/7 • Number of events 1 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Vascular disorders
hot / cold flashes
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Ear and labyrinth disorders
difficulty hearing in right ear
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Eye disorders
bloodshot eyes
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Vascular disorders
hypertension
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Reproductive system and breast disorders
menstrual cramps
|
0.00%
0/7 • 8 weeks
|
0.00%
0/7 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
Additional Information
Jeff Theobald
UC COM Psychiatry Dept. -- Addiction Sciences Division
Phone: 5135858281
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place