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Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural processes that encode, interpret, and respond to socially and emotionally relevant stimuli) have been implicated in tobacco smoking and relapse, however this potential target for medication development has not been systematically examined. Evidence from animal and human laboratories indicate that administration of intranasal oxytocin enhances socioemotional processing and may be efficacious for the treatment of drug addiction, including nicotine dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular smokers following overnight abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then Intranasal Oxytocin (40 IU) | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Lapse Analogue Task (Delay Score) | 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. | 2.5 hours after nasal spray administration |
| Brief Questionnaire of Smoking Urges (QSU) | The 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. | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
| Systolic Blood Pressure (mmHg) | Systolic 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. | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
| Diastolic Blood Pressure (mmHg) | Diastolic 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. | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
| Heart Rate (Bpm) | Heart 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States (Anxious Scale) | The 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Kirkpatrick, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Health, Emotion and Addiction Laboratory | Los Angeles | California | 90032 | United States |
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No participants were excluded pre-assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Lapse Analogue Task (Delay Score) | 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. | Posted | Mean | Standard Error | minutes | 2.5 hours after nasal spray administration |
|
2 years, 6 months
The definition of adverse event and/or serious adverse event used to collect adverse event information in the current study did not differ from the clinicaltrials.gov definitions. Participants were monitored during experimental sessions in person and then for a week following study participation (by phone call each day).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Oxytocin (40 IU) | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Kirkpatrick | USC Dept. of Preventive Medicine | 3234428221 | mgkirkpa@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2017 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug |
|
|
| 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
| 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
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. |
|
|
| Primary | Brief Questionnaire of Smoking Urges (QSU) | The 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. | Posted | Mean | Standard Error | score on a scale | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
|
|
|
| Primary | Systolic Blood Pressure (mmHg) | Systolic 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. | Posted | Mean | Standard Error | mmHg | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
|
|
|
| Primary | Diastolic Blood Pressure (mmHg) | Diastolic 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. | Posted | Mean | Standard Error | mmHg | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
|
|
|
| Primary | Heart Rate (Bpm) | Heart 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. | Posted | Mean | Standard Error | bpm | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
|
|
|
| Secondary | Profile of Mood States (Anxious Scale) | The 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. | Posted | Mean | Standard Error | score on a scale | 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Placebo | 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. | 0 | 64 | 0 | 64 | 0 | 64 |
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| D001519 |
| Behavior |
| D064424 | Tobacco Use |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |