Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 9:29 AM
Study NCT ID:
NCT00809835
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2008-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005702', 'term': 'Galantamine'}], 'ancestors': [{'id': 'D047151', 'term': 'Amaryllidaceae Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathleen.carroll@yale.edu', 'phone': '203.937.3486', 'title': 'Kathleen M. Carroll, Ph.D., Albert E Kent Professor of Psychiatry', 'phoneExt': '7403', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Galantamine and CBT', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine\n\nBehavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.', 'otherNumAtRisk': 28, 'otherNumAffected': 15, 'seriousNumAtRisk': 28, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Galantamine', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine', 'otherNumAtRisk': 27, 'otherNumAffected': 10, 'seriousNumAtRisk': 27, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo and CBT', 'description': 'Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.', 'otherNumAtRisk': 38, 'otherNumAffected': 16, 'seriousNumAtRisk': 38, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Placebo Only', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.", 'otherNumAtRisk': 27, 'otherNumAffected': 14, 'seriousNumAtRisk': 27, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Blood in Stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Loss of Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Diarrhea or Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Inpatient Substance Use Treatment Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Inpatient Psychiatric Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Medical hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Medical hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Medical Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Galantamine and CBT', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine\n\nBehavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.'}, {'id': 'OG001', 'title': 'Galantamine', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine'}, {'id': 'OG002', 'title': 'Placebo and CBT', 'description': 'Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.'}, {'id': 'OG003', 'title': 'Placebo Only', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.82', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '14.81', 'spread': '9.05', 'groupId': 'OG001'}, {'value': '15.68', 'spread': '7.78', 'groupId': 'OG002'}, {'value': '14.85', 'spread': '8.47', 'groupId': 'OG003'}]}]}, {'title': '12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.60', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '6.52', 'groupId': 'OG001'}, {'value': '7.65', 'spread': '7.41', 'groupId': 'OG002'}, {'value': '10.25', 'spread': '7.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks.'}, {'type': 'PRIMARY', 'title': 'Cocaine Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Galantamine and CBT', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine\n\nBehavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.'}, {'id': 'OG001', 'title': 'Galantamine', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine'}, {'id': 'OG002', 'title': 'Placebo and CBT', 'description': 'Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.'}, {'id': 'OG003', 'title': 'Placebo Only', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered."}], 'classes': [{'categories': [{'measurements': [{'value': '22.45', 'spread': '35.62', 'groupId': 'OG000'}, {'value': '31.13', 'spread': '34.16', 'groupId': 'OG001'}, {'value': '20.49', 'spread': '27.60', 'groupId': 'OG002'}, {'value': '14.78', 'spread': '19.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks', 'unitOfMeasure': 'percentage of negative urines', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment.'}, {'type': 'SECONDARY', 'title': 'Cognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Galantamine and CBT', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine\n\nBehavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.'}, {'id': 'OG001', 'title': 'Galantamine', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine'}, {'id': 'OG002', 'title': 'Placebo and CBT', 'description': 'Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.'}, {'id': 'OG003', 'title': 'Placebo Only', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered."}], 'classes': [{'categories': [{'measurements': [{'value': '-.12', 'spread': '.58', 'groupId': 'OG000'}, {'value': '.11', 'spread': '.50', 'groupId': 'OG001'}, {'value': '-.06', 'spread': '.71', 'groupId': 'OG002'}, {'value': '.03', 'spread': '.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span).\n\nScores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants did not complete the CANTAB assessments at both pre and post treatment. Reasons for not completing were refusal to complete the tasks, inability to complete the tasks in a manner in which they could be scored and equipment or computer problems.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Galantamine and CBT', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.'}, {'id': 'FG001', 'title': 'Galantamine Only', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine'}, {'id': 'FG002', 'title': 'Placebo and CBT', 'description': 'TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.'}, {'id': 'FG003', 'title': 'Placebo Only', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Galantamine and CBT', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine\n\nBehavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.'}, {'id': 'BG001', 'title': 'Galantamine', 'description': 'Drug: Galantamine Daily 8 mg galantamine capsule\n\nOther Names:\n\nNivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine'}, {'id': 'BG002', 'title': 'Placebo and CBT', 'description': 'Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.'}, {'id': 'BG003', 'title': 'Placebo Only', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.04', 'spread': '8.72', 'groupId': 'BG000'}, {'value': '38.70', 'spread': '10.79', 'groupId': 'BG001'}, {'value': '39.82', 'spread': '8.99', 'groupId': 'BG002'}, {'value': '36.30', 'spread': '9.41', 'groupId': 'BG003'}, {'value': '38.36', 'spread': '9.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'Multiracial/Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2008-12-16', 'resultsFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2008-12-16', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cocaine Use', 'timeFrame': '12 weeks', 'description': 'Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.'}, {'measure': 'Cocaine Abstinence', 'timeFrame': '12 weeks', 'description': 'operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Cognitive Function', 'timeFrame': '12 weeks', 'description': 'A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span).\n\nScores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cocaine', 'Methadone', 'CBT'], 'conditions': ['Cocaine Dependence']}, 'referencesModule': {'references': [{'pmid': '29286595', 'type': 'DERIVED', 'citation': 'Carroll KM, Nich C, DeVito EE, Shi JM, Sofuoglu M. Galantamine and Computerized Cognitive Behavioral Therapy for Cocaine Dependence: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11669. doi: 10.4088/JCP.17m11669.'}]}, 'descriptionModule': {'briefSummary': 'We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.', 'detailedDescription': 'We are proposing a randomized double blind clinical trial of galantamine and our innovative computer-assisted version of CBT, alone and in combination, to improve treatment outcome and cognitive functioning among cocaine users. The proposed study will be the first to evaluate a cognitive enhancing medication as a means of enhancing the effects of an extremely promising empirically validated behavioral therapy for addiction, and hence bridge cognitive neuroscience and behavioral therapies development.\n\nThe aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial model, that will evaluate the efficacy of adding computer assisted training in CBT ("CBT4CBT") and galantamine to standard treatment for 160 cocaine abusing or dependent methadone-maintained individuals. Participants will be randomized to (1) standard treatment (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU plus CBT4CBT plus galantamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between ages of 18 and 50\n* Enrolled in RNP methadone program and stable on methadone for at least 3 weeks\n* Current cocaine abuse or dependence according to DSM-IV criteria\n* No current medical problems and normal ECG\n* If female, not currently pregnant or breast feeding and using reliable birth control\n* Fluent in English and have at least a 6th grade reading level\n* Can commit to 12 weeks of treatment and are willing to be randomized\n\nExclusion Criteria:\n\n* Current major psychiatric illness including mood, psychotic or anxiety disorder\n* History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances\n* Use of medications including beta blockers and NASAIDs\n* Known allergy to Galantamine'}, 'identificationModule': {'nctId': 'NCT00809835', 'briefTitle': 'Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals', 'orgStudyIdInfo': {'id': '0708002943'}, 'secondaryIdInfos': [{'id': 'R01DA015969-13', 'link': 'https://reporter.nih.gov/quickSearch/R01DA015969-13', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Treatment As Usual (TAU)', 'description': "Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered."}, {'type': 'EXPERIMENTAL', 'label': 'TAU Plus Galantamine', 'description': 'Standard treatment plus Galantamine. In this study, we will use 8 mg galantamine extended release (ER). Galantamine ER is used once daily. The recommended initial dose is 8 mg/day and the maintenance dose is 16-24 mg/day.', 'interventionNames': ['Drug: Galantamine']}, {'type': 'EXPERIMENTAL', 'label': 'TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)', 'description': 'TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.', 'interventionNames': ['Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)']}, {'type': 'EXPERIMENTAL', 'label': 'TAU plus CBT plus galantamine', 'description': 'Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.', 'interventionNames': ['Drug: Galantamine', 'Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)']}], 'interventions': [{'name': 'Galantamine', 'type': 'DRUG', 'otherNames': ['Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine'], 'description': 'Daily 8 mg galantamine capsule', 'armGroupLabels': ['TAU Plus Galantamine', 'TAU plus CBT plus galantamine']}, {'name': 'Computer Assisted Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.', 'armGroupLabels': ['TAU plus CBT plus galantamine', 'TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06604', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Kinsella Treatment Center (KTC)', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06615', 'city': 'Stratford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Regional Network of Programs', 'geoPoint': {'lat': 41.18454, 'lon': -73.13317}}], 'overallOfficials': [{'name': 'Kathleen M Carroll, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data will be available to other researchers upon request. Please contact Dr. Carroll'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}