Trial Outcomes & Findings for Effects of Intranasal Oxytocin on Cigarette Smoking (NCT NCT02595749)
NCT ID: NCT02595749
Last Updated: 2021-11-15
Results Overview
This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (minimum = 0 minutes to maximum = 50 minutes). A higher number is better.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
2.5 hours after nasal spray administration
Results posted on
2021-11-15
Participant Flow
No participants were excluded pre-assignment.
Participant milestones
| Measure |
Placebo Then Intranasal Oxytocin (40 IU)
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
Oxytocin
|
Intranasal Oxytocin (40 IU) Then Placebo
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
38
|
|
Overall Study
COMPLETED
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Placebo Then Intranasal Oxytocin (40 IU)
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
Oxytocin
|
Intranasal Oxytocin (40 IU) Then Placebo
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
7
|
Baseline Characteristics
Effects of Intranasal Oxytocin on Cigarette Smoking
Baseline characteristics by cohort
| Measure |
Placebo Then Intranasal Oxytocin (40 IU)
n=45 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Intranasal Oxytocin (40 IU) Then Placebo
n=38 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first experimental session, which occurred on a single day. After a 72 hour washout period, they then received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the second experimental session, which occurred on a single day. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
70 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
38 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.5 hours after nasal spray administrationThis task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (minimum = 0 minutes to maximum = 50 minutes). A higher number is better.
Outcome measures
| Measure |
Intranasal Oxytocin (40 IU)
n=64 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Placebo
n=64 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Smoking Lapse Analogue Task (Delay Score)
|
11.5 minutes
Standard Error 2.3
|
10.9 minutes
Standard Error 2.3
|
PRIMARY outcome
Timeframe: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal sprayThe Brief Questionnaire of Smoking Urges (QSU) is a 10-item self-report questionnaire measures desire, intention, urge, and need to smoke. The QSU was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Scores at each assessment time are calculated as the mean of all 10 items (minimum = 0 to maximum = 5). Each session's scores are then calculated as the mean scores of post-spray assessments. A lower score is better.
Outcome measures
| Measure |
Intranasal Oxytocin (40 IU)
n=64 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Placebo
n=64 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Brief Questionnaire of Smoking Urges (QSU)
|
2.46 score on a scale
Standard Error 0.12
|
2.49 score on a scale
Standard Error .11
|
PRIMARY outcome
Timeframe: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spraySystolic blood pressure (SP) was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's values are calculated as the mean of post-spray assessments.
Outcome measures
| Measure |
Intranasal Oxytocin (40 IU)
n=64 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Placebo
n=64 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Systolic Blood Pressure (mmHg)
|
122.1 mmHg
Standard Error 1.4
|
118.2 mmHg
Standard Error 1.4
|
PRIMARY outcome
Timeframe: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal sprayDiastolic blood pressure (DP) was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's values are calculated as the mean of post-spray assessments.
Outcome measures
| Measure |
Intranasal Oxytocin (40 IU)
n=64 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Placebo
n=64 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Diastolic Blood Pressure (mmHg)
|
77.5 mmHg
Standard Error 1.1
|
74.7 mmHg
Standard Error 1.1
|
PRIMARY outcome
Timeframe: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal sprayHeart rate (HR) was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's values are calculated as the mean of post-spray assessments.
Outcome measures
| Measure |
Intranasal Oxytocin (40 IU)
n=64 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Placebo
n=64 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Heart Rate (Bpm)
|
65.6 bpm
Standard Error 0.7
|
65.9 bpm
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal sprayThe Profile of Mood States (POMS) lists 72 affective adjectives that are rated on 0 to 4-point. The main measure for this study is the Anxious scale, calculated as the mean of 6 anxiety-related items. The POMS was assessed 30 minutes before the nasal spray, and again 30, 60, and 90 minutes after the nasal spray during each session. Each session's scores are calculated as the mean scores of post-spray assessments. Lower scores are better.
Outcome measures
| Measure |
Intranasal Oxytocin (40 IU)
n=64 Participants
Participants received a single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
Placebo
n=64 Participants
Participants received a single placebo nasal spray (consisting of 4ml sterile saline \[Ocean Nasal Spray Solution\]) during the first or second experimental session. The second experimental session was completed at least 72 hours after the first. All nasal spray solutions were transferred into two, 2 ml intranasal atomizers and administered in four sprays to each nostril over the course of 10 minutes.
|
|---|---|---|
|
Profile of Mood States (Anxious Scale)
|
0.82 score on a scale
Standard Error .04
|
0.71 score on a scale
Standard Error .04
|
Adverse Events
Intranasal Oxytocin (40 IU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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