Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT00573859
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Reinforcing Mechanisms of Smoking in Adult ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}, {'id': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}], 'ancestors': [{'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011437', 'term': 'Propylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgehrick@uci.edu', 'phone': '949-824-1834', 'title': 'Jean Gehricke, Ph.D.', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ADHD Medication Versus Placebo', 'description': 'Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Effects of ADHD Medication Versus Placebo on Cotinine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD Medication Versus Placebo', 'description': 'Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.'}], 'classes': [{'title': 'ADHD medication', 'categories': [{'measurements': [{'value': '180.7', 'spread': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Placebo', 'categories': [{'measurements': [{'value': '274.0', 'spread': '70.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'groupDescription': 'A 2 (ADHD medication versus Placebo) repeated measure ANOVA', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Smokers with ADHD'}, {'type': 'SECONDARY', 'title': 'The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD Medication Versus Placebo', 'description': 'Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.'}], 'classes': [{'title': 'ADHD medication + Smoking', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'ADHD medication + Abstinence', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Placebo + Smoking', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Placebo + Abstinence', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Four-way repeated measure ANOVA', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.', 'unitOfMeasure': 'errors', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ADHD Medication Versus Placebo', 'description': 'Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.'}], 'classes': [{'title': 'ADHD medication + Smoking', 'categories': [{'measurements': [{'value': '92.7', 'spread': '2.9', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '123'}]}]}, {'title': 'ADHD medication + Abstinence', 'categories': [{'measurements': [{'value': '91.3', 'spread': '3.5', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '132'}]}]}, {'title': 'Placebo + Smoking', 'categories': [{'measurements': [{'value': '97.0', 'spread': '4.8', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '137'}]}]}, {'title': 'Placebo + Abstinence', 'categories': [{'measurements': [{'value': '102.0', 'spread': '4.8', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '161'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'groupDescription': "Friedman's two-way analysis of variance by ranks.", 'statisticalMethod': "Friedman's two analysis of ranks", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '4 days', 'description': 'The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ADHD Medication Versus Placebo', 'description': 'Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.'}], 'periods': [{'title': 'Medication Versus Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Scheduling conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}, {'title': 'Smoking Versus Abstinence', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Scheduling conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ADHD Medication Versus Placebo', 'description': 'Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-23', 'studyFirstSubmitDate': '2007-12-12', 'resultsFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-23', 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effects of ADHD Medication Versus Placebo on Cotinine Levels', 'timeFrame': '4 days', 'description': 'Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.'}], 'secondaryOutcomes': [{'measure': 'The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.', 'timeFrame': '4 days', 'description': 'In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.'}, {'measure': 'The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.', 'timeFrame': '4 days', 'description': 'The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking', 'ADHD', 'Stimulant medication'], 'conditions': ['ADHD']}, 'referencesModule': {'references': [{'pmid': '21356232', 'type': 'RESULT', 'citation': 'Gehricke JG, Hong N, Wigal TL, Chan V, Doan A. ADHD medication reduces cotinine levels and withdrawal in smokers with ADHD. Pharmacol Biochem Behav. 2011 May;98(3):485-91. doi: 10.1016/j.pbb.2011.02.021. Epub 2011 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'Whereas the smoking prevalence rates in the general population are declining, rates among people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be elevated. Smoking may be a form of self-medication in people with ADHD, which has specific reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and arousal, or a combination of both. In addition, the reinforcing effects of smoking may be potentiated by stimulant medication.\n\nThe study examined the reinforcing effects of ad libitum smoking with and without ADHD medication in adult smokers with clinically diagnosed ADHD. Participants were adults with ADHD. The effects of two day of ADHD medication compared to two days on placebo for were studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the Continuous Performance Task and nicotine withdrawal symptoms were examined in response to ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo medication + smoking versus placebo medication + abstinence.\n\nThe study identified the reinforcing mechanisms of smoking in interaction with ADHD medication. The findings will contribute to a better understanding of nicotine addiction and facilitate the development of targeted smoking cessation and prevention programs for individuals with ADHD and other people with deficiencies in impulse control and excessive risk taking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An age of 18 to 45 years\n* A history of ADHD\n* Current diagnosis of ADHD according to clinical criteria\n* Current treatment with stimulant medication\n* Smoking of 10 cigarettes or more per day\n\nExclusion Criteria:\n\n* Treatment for any major medical illness such as cancer, heart disease, diabetes, skin diseases, current major depressive episode, and schizophrenia even if currently controlled by medication\n* Current pregnancy, as measured by a pregnancy test (Clear Blue Easy, Unipath, Bedford, UK), or planning to become pregnant within the next 6 months. These individuals will not be included because smoking may cause harm to the unborn fetus\n* Nursing mothers\n* Non-English speaking people, because the majority of measurements used in the study have not been validated in languages other than English'}, 'identificationModule': {'nctId': 'NCT00573859', 'briefTitle': 'The Reinforcing Mechanisms of Smoking in Adult ADHD', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'The Reinforcing Mechanisms of Smoking in Adult ADHD', 'orgStudyIdInfo': {'id': '2006-5156'}, 'secondaryIdInfos': [{'id': 'NIH grant# DA018752'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADHD medication versus placebo', 'description': 'For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication (e.g., Dextroamphetamine; Amphetamine mixed salts; Atomoxetine; O-Methylphenidate; Lisdexamfetamine). For the placebo condition, a placebo pill was administered.', 'interventionNames': ['Drug: ADHD medication', 'Drug: Placebo']}], 'interventions': [{'name': 'ADHD medication', 'type': 'DRUG', 'otherNames': ['Dextroamphetamine', 'Amphetamine mixed salts', 'Atomoxetine', 'O-Methylphenidate', 'Lisdexamfetamine'], 'description': 'For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.', 'armGroupLabels': ['ADHD medication versus placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'For the placebo condition, participants received placebo pills for two consecutive days.', 'armGroupLabels': ['ADHD medication versus placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Department of Pediatrics', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Jean G Gehricke, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}