Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-27 @ 1:23 PM
Study NCT ID:
NCT00606892
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2008-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Varenicline and Nicotine Interactions in Humans (VA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mehmet.sofuoglu@yale.edu', 'phone': '203-937-4809', 'title': 'Mehmet Sofuoglu, M.D., Ph.D.', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo First, Then Varenicline, First Intervention', 'description': 'Subjects received a placebo tablet once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Varenicline First, Then Placebo, First Intervention', 'description': 'Subjects received varenicline once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Adaptation - Placebo First, Then Varenicline', 'description': "Subjects randomized to the 'Placebo first' condition participated in a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability prior to the study medication intervention.", 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Adaptation - Varenicline First, Then Placebo', 'description': "Subjects randomized to the 'Varenicline first' condition first received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability before receiving the study medication.", 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo First, Then Varenicline, Second Intervention', 'description': 'Subjects crossed-over from the first intervention and received varenicline once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Varenicline First, Then Placebo, Second Intervention', 'description': 'Subjects crossed-over from the first intervention (varenicline) and received placebo once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean Reaction Time (RT) on Modified Stroop Task.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo, Pre-Nicotine', 'description': 'Mean reaction time during modified Stroop task under the placebo condition and prior to the nicotine infusions.'}, {'id': 'OG001', 'title': 'Placebo, Post-Nicotine', 'description': 'Mean reaction time during modified Stroop task under the placebo condition and 30 minutes after the nicotine infusions.'}, {'id': 'OG002', 'title': 'Varenicline, Pre-Nicotine', 'description': 'Mean reaction time during modified Stroop task under the varenicline condition prior to the nicotine infusions.'}, {'id': 'OG003', 'title': 'Varenicline, Post-Nicotine', 'description': 'Mean reaction time during modified Stroop task under the varenicline condition and 30 minutes after the nicotine infusions.'}], 'classes': [{'title': 'Smoking Block', 'categories': [{'measurements': [{'value': '722.3', 'spread': '131.3', 'groupId': 'OG000'}, {'value': '693.1', 'spread': '129.4', 'groupId': 'OG001'}, {'value': '660.1', 'spread': '137.8', 'groupId': 'OG002'}, {'value': '624.2', 'spread': '100.1', 'groupId': 'OG003'}]}]}, {'title': 'Neutral Block- Smoking Cue', 'categories': [{'measurements': [{'value': '702.3', 'spread': '148.6', 'groupId': 'OG000'}, {'value': '686.7', 'spread': '134.1', 'groupId': 'OG001'}, {'value': '652.1', 'spread': '115.5', 'groupId': 'OG002'}, {'value': '618.6', 'spread': '104.7', 'groupId': 'OG003'}]}]}, {'title': 'Negative Affect block', 'categories': [{'measurements': [{'value': '679.0', 'spread': '104.1', 'groupId': 'OG000'}, {'value': '641.3', 'spread': '114.9', 'groupId': 'OG001'}, {'value': '665.8', 'spread': '177.1', 'groupId': 'OG002'}, {'value': '631.7', 'spread': '128.6', 'groupId': 'OG003'}]}]}, {'title': 'Neutral Block- Negative Affect Cue', 'categories': [{'measurements': [{'value': '692.5', 'spread': '117.5', 'groupId': 'OG000'}, {'value': '661.5', 'spread': '111.1', 'groupId': 'OG001'}, {'value': '644.8', 'spread': '122.8', 'groupId': 'OG002'}, {'value': '618.6', 'spread': '108.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).', 'groupDescription': 'A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)', 'description': 'A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Data from all subjects who completed both experimental sessions (nicotine infusion after 4 days of placebo and also 4 days of varneicline, n=12) are presented. RT's \\< 100 ms, or \\> 1501 ms were excluded from the analysis (\\>3 SD's of the mean). The data presented are the mean RT's to identifying word colors under each treatment condition."}, {'type': 'SECONDARY', 'title': 'Cotinine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The mean cotinine levels for subjects under the placebo condition.'}, {'id': 'OG001', 'title': 'Varenicline (1 mg)', 'description': 'The mean cotinine levels for subjects under the varenicline condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '202', 'spread': '41', 'groupId': 'OG000'}, {'value': '185', 'spread': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.3', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '40', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F(1,10)=1.1', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before each laboratory session on day 5', 'description': 'Subject Cotinine Levels before each laboratory session.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects finishing the complete study. (n=12)'}, {'type': 'PRIMARY', 'title': 'Subjective Responses to Intravenous Nicotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/ Low Dose Nictoine', 'description': 'The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the placebo condition.'}, {'id': 'OG001', 'title': 'Placebo/ Medium Dose Nicotine', 'description': 'The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the placebo condition.'}, {'id': 'OG002', 'title': 'Placebo/High Dose Nicotine', 'description': 'The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the placebo condition.'}, {'id': 'OG003', 'title': 'Varenicline/ Low Dose Nicotine', 'description': 'The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the varenicline condition.'}, {'id': 'OG004', 'title': 'Varenicline/ Medium Dose Nicotine', 'description': 'The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the varenicline condition.'}, {'id': 'OG005', 'title': 'Varenicline/ High Dose Nicotine', 'description': 'The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the varenicline condition.'}], 'classes': [{'title': 'High', 'categories': [{'measurements': [{'value': '23', 'spread': '8', 'groupId': 'OG000'}, {'value': '38', 'spread': '10', 'groupId': 'OG001'}, {'value': '51', 'spread': '10', 'groupId': 'OG002'}, {'value': '14', 'spread': '4', 'groupId': 'OG003'}, {'value': '27', 'spread': '7', 'groupId': 'OG004'}, {'value': '37', 'spread': '8', 'groupId': 'OG005'}]}]}, {'title': 'Head Rush', 'categories': [{'measurements': [{'value': '24', 'spread': '8', 'groupId': 'OG000'}, {'value': '40', 'spread': '9', 'groupId': 'OG001'}, {'value': '51', 'spread': '9', 'groupId': 'OG002'}, {'value': '11', 'spread': '4', 'groupId': 'OG003'}, {'value': '28', 'spread': '7', 'groupId': 'OG004'}, {'value': '37', 'spread': '8', 'groupId': 'OG005'}]}]}, {'title': 'Feels Stimulated', 'categories': [{'measurements': [{'value': '25', 'spread': '8', 'groupId': 'OG000'}, {'value': '34', 'spread': '10', 'groupId': 'OG001'}, {'value': '38', 'spread': '10', 'groupId': 'OG002'}, {'value': '11', 'spread': '4', 'groupId': 'OG003'}, {'value': '24', 'spread': '8', 'groupId': 'OG004'}, {'value': '35', 'spread': '9', 'groupId': 'OG005'}]}]}, {'title': 'Drug Strength', 'categories': [{'measurements': [{'value': '24', 'spread': '8', 'groupId': 'OG000'}, {'value': '41', 'spread': '9', 'groupId': 'OG001'}, {'value': '58', 'spread': '09', 'groupId': 'OG002'}, {'value': '16', 'spread': '4', 'groupId': 'OG003'}, {'value': '32', 'spread': '7', 'groupId': 'OG004'}, {'value': '40', 'spread': '8', 'groupId': 'OG005'}]}]}, {'title': 'Bad Effects', 'categories': [{'measurements': [{'value': '7', 'spread': '3', 'groupId': 'OG000'}, {'value': '15', 'spread': '7', 'groupId': 'OG001'}, {'value': '23', 'spread': '8', 'groupId': 'OG002'}, {'value': '8', 'spread': '3', 'groupId': 'OG003'}, {'value': '8', 'spread': '3', 'groupId': 'OG004'}, {'value': '20', 'spread': '8', 'groupId': 'OG005'}]}]}, {'title': 'Good Effects', 'categories': [{'measurements': [{'value': '19', 'spread': '8', 'groupId': 'OG000'}, {'value': '30', 'spread': '8', 'groupId': 'OG001'}, {'value': '45', 'spread': '10', 'groupId': 'OG002'}, {'value': '22', 'spread': '8', 'groupId': 'OG003'}, {'value': '25', 'spread': '8', 'groupId': 'OG004'}, {'value': '34', 'spread': '9', 'groupId': 'OG005'}]}]}, {'title': 'Like the Drug', 'categories': [{'measurements': [{'value': '18', 'spread': '8', 'groupId': 'OG000'}, {'value': '27', 'spread': '9', 'groupId': 'OG001'}, {'value': '35', 'spread': '10', 'groupId': 'OG002'}, {'value': '14', 'spread': '4', 'groupId': 'OG003'}, {'value': '25', 'spread': '8', 'groupId': 'OG004'}, {'value': '35', 'spread': '9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'pValueComment': 'Values of p\\<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p\\<0.016.', 'groupDescription': 'A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after each nicotine infusion', 'description': 'The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: \'drug strength\',\' high\', \'feels stimulated\', \'good effects\', \'bad effects\', \'head rush\', and \'like the drug\'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complete all interventions.'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Low Dose Nicotine', 'description': 'The average peak change (change score) in heart rate after nicotine (0.1mg per70kg) infusion under the placebo condition.'}, {'id': 'OG001', 'title': 'Placebo/ Medium Dose Nicotine', 'description': 'The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the placebo condition.'}, {'id': 'OG002', 'title': 'Placebo/High Dose Nicotine', 'description': 'The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the placebo condition.'}, {'id': 'OG003', 'title': 'Varenicline/ Low Dose Nicotine', 'description': 'The average peak change (change score) in heart rate after nicotine (0.1mg per 70kg) infusion under the varenicline condition.'}, {'id': 'OG004', 'title': 'Varenicline/ Medium Dose Nicotine', 'description': 'The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the varenicline condition.'}, {'id': 'OG005', 'title': 'Varenicline / High Dose Nicotine', 'description': 'The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the varenicline condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '1', 'groupId': 'OG000'}, {'value': '13', 'spread': '2', 'groupId': 'OG001'}, {'value': '16', 'spread': '2', 'groupId': 'OG002'}, {'value': '2', 'spread': '2', 'groupId': 'OG003'}, {'value': '5', 'spread': '1', 'groupId': 'OG004'}, {'value': '5', 'spread': '2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P\\<0.016', 'groupDescription': 'A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-tailed tests were applied for main effects with P\\<0.05', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after each nicotine infusion', 'description': 'The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).'}, {'type': 'SECONDARY', 'title': 'Changes in Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Low Dose Nicotine', 'description': 'The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the placebo condition.'}, {'id': 'OG001', 'title': 'Placebo/ Medium Dose Nicotine', 'description': 'The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the placebo condition.'}, {'id': 'OG002', 'title': 'Placebo/High Dose Nicotine', 'description': 'The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the placebo condition.'}, {'id': 'OG003', 'title': 'Varenicline/ Low Dose Nicotine', 'description': 'The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the varenicline condition.'}, {'id': 'OG004', 'title': 'Varenicline/ Medium Dose Nicotine', 'description': 'The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the varenicline condition.'}, {'id': 'OG005', 'title': 'Varenicline / High Dose Nicotine', 'description': 'The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the varenicline condition.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '12', 'spread': '4', 'groupId': 'OG000'}, {'value': '16', 'spread': '2', 'groupId': 'OG001'}, {'value': '8', 'spread': '3', 'groupId': 'OG002'}, {'value': '7', 'spread': '2', 'groupId': 'OG003'}, {'value': '13', 'spread': '3', 'groupId': 'OG004'}, {'value': '16', 'spread': '3', 'groupId': 'OG005'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '7', 'spread': '2', 'groupId': 'OG000'}, {'value': '6', 'spread': '2', 'groupId': 'OG001'}, {'value': '5', 'spread': '1', 'groupId': 'OG002'}, {'value': '5', 'spread': '2', 'groupId': 'OG003'}, {'value': '6', 'spread': '2', 'groupId': 'OG004'}, {'value': '7', 'spread': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after each nicotine infusion', 'description': 'The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First, Then Varenicline', 'description': 'Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).'}, {'id': 'FG001', 'title': 'Varenicline First, Then Placebo', 'description': 'Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).'}], 'periods': [{'title': 'Adaptation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the New Haven Connecticut area through newspaper advertisements and fliers from the summer of 2007 thru the winter of 2008.', 'preAssignmentDetails': 'There was no special pre-assignment procedures for this study. Thirty seven smokers signed a consent form with only 17 randomized. 13 smokers never return to clinic after signing a consent form. 2 smokers were excluded secondary to poor IV access. 5 smokers had dropped out due to a scheduling conflict.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '37 subjects signed consent. 17 subjects received the first treatment. Five subjects dropped out due to non-compliance with study procedures prior to study completion, and therefore were not included in the analysis. The 12 subjects who completed both interventions were included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2008-01-23', 'resultsFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-09', 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Responses to Intravenous Nicotine', 'timeFrame': '30 minutes after each nicotine infusion', 'description': 'The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: \'drug strength\',\' high\', \'feels stimulated\', \'good effects\', \'bad effects\', \'head rush\', and \'like the drug\'. Smokers rated each item on a 100 millimeter scale from "not at all" (a score of 0) to "extremely" with a maximum score of 100.'}], 'secondaryOutcomes': [{'measure': 'Mean Reaction Time (RT) on Modified Stroop Task.', 'timeFrame': 'pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)', 'description': 'A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).'}, {'measure': 'Cotinine Levels', 'timeFrame': 'Before each laboratory session on day 5', 'description': 'Subject Cotinine Levels before each laboratory session.'}, {'measure': 'Heart Rate', 'timeFrame': '30 minutes after each nicotine infusion', 'description': 'The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.'}, {'measure': 'Changes in Systolic and Diastolic Blood Pressure', 'timeFrame': '30 minutes after each nicotine infusion', 'description': 'The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['therapeutic effects'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '19693492', 'type': 'RESULT', 'citation': 'Sofuoglu M, Herman AI, Mooney M, Waters AJ. Varenicline attenuates some of the subjective and physiological effects of intravenous nicotine in humans. Psychopharmacology (Berl). 2009 Nov;207(1):153-62. doi: 10.1007/s00213-009-1643-z. Epub 2009 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.', 'detailedDescription': 'This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male smokers, aged 18 to 55 years\n* History of smoking daily for the past 12 months, at least 15 cigarettes daily\n* Carbon Monoxide (Alveolar) level \\> 10ppm\n* For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods\n\nExclusion Criteria:\n\n* History of heart disease, renal or hepatic diseases\n* other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study\n* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)\n* recent psychiatric diagnosis and treatment for Axis I disorders including\n* major depression, bipolar affective disorder,\n* schizophrenia and panic disorder within the past year\n* Current dependence on alcohol\n* drugs or treatments for drug\n* alcohol addiction within the past 5 years\n* Allergy to varenicline'}, 'identificationModule': {'nctId': 'NCT00606892', 'briefTitle': 'Varenicline and Nicotine Interactions in Humans (VA)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.', 'orgStudyIdInfo': {'id': 'HIC # 0702002338'}, 'secondaryIdInfos': [{'id': 'MIRECC 000000000', 'type': 'REGISTRY', 'domain': "Department of Veteran's Affairs"}, {'id': 'DPMC', 'type': 'OTHER', 'domain': 'NIDA'}, {'id': 'R01DA014537', 'link': 'https://reporter.nih.gov/quickSearch/R01DA014537', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo First, varenicline, + IV Nic', 'description': 'Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,0.7 mg per 70kg).', 'interventionNames': ['Drug: Varenicline', 'Drug: Placebo', 'Drug: IV Nic']}, {'type': 'EXPERIMENTAL', 'label': 'Varenicline first, placebo, + IV Nic', 'description': 'Subjects received Varenicline tablet (1 mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg). After a washout of a minimum of 5 days subjects then received placebo tablet for per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1,0.4,, and 0.7mg per 70 kg).', 'interventionNames': ['Drug: Varenicline', 'Drug: Placebo', 'Drug: IV Nic']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'Varenicline (1 mg per day) given for 4 days prior to laboratory session', 'armGroupLabels': ['Placebo First, varenicline, + IV Nic', 'Varenicline first, placebo, + IV Nic']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Sugar Pill', 'armGroupLabels': ['Placebo First, varenicline, + IV Nic', 'Varenicline first, placebo, + IV Nic']}, {'name': 'IV Nic', 'type': 'DRUG', 'otherNames': ['IV Nicotine'], 'description': 'IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which followed the 4 days of exposure to either placebo then varenicline or varenicline then placebo.', 'armGroupLabels': ['Placebo First, varenicline, + IV Nic', 'Varenicline first, placebo, + IV Nic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Veterans Affairs Hospital', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Mehmet Sofuoglu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University Associate Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}