Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT04035603
Status:
WITHDRAWN
Last Update Posted:
2021-02-12
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Cue Exposure Therapy for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Never received funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Prolonged Abstinence (PA)', 'timeFrame': 'Prolonged abstinence is assessed from Quit week to Week 24 of Follow-up', 'description': 'Failure to maintain PA at any assessment will be defined by 7 or more consecutive days of smoking or smoking at least 1 cigarette over the 2 consecutive weeks prior to the assessment'}, {'measure': 'Rates of Point Prevalence Abstinence (PPA)', 'timeFrame': 'Point Prevalence Abstinence is assessed from Quit Week to 24 week Follow-up using a growth curve model', 'description': 'PPA is defined as no smoking in the 7 days prior to any assessment. Self-report is verified with saliva cotinine.'}], 'secondaryOutcomes': [{'measure': 'Cue-Induces Patient Rating of Craving for Cigarettes', 'timeFrame': 'Post-quit weeks 0, 1, 2, 9, and 10', 'description': 'Cravings in response to visual, in vivo, imaginal, and VR smoking cues rated according to a 0 to 11 visual analogue scale; higher scores represent higher craving levels.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'At two sites (Boston University and the University of Texas at Austin, under the MPI direction of Drs. Otto and Smits) the investigators propose to randomly assign 240 adult smokers who have achieved short-term abstinence following open treatment with a 4 session cognitive-behavior therapy program combined with medication (nicotine patch, varenicline, or bupropion, selected openly) to (1) d-cycloserine augmentation of multimodal cue exposure therapy (CET), or (2) placebo augmentation of multimodal CET. This Stage II project is designed to: (1) evaluate the short-term and long-term efficacy of the experimental intervention, (2) further test putative mechanisms of change, (3) explore possible moderator effects of theoretically-relevant variables, and (4) use innovative, multimodal CET strategies. Putative mediators and smoking abstinence will be assessed during the intervention period and up to 6 months following the quit attempt.', 'detailedDescription': "This study utilizes on open phase of 4-sessions of cognitive-behavior therapy for smoking cessation that is combined with open pharmacotherapy (selected by participants in collaboration with the study medical team: nicotine patch, varenicline, or bupropion). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention). The study therapists will also make a supportive phone call on the day of the quit attempt, with repeated check-in calls over the quit window (i.e., weeks 4-6) as needed for individuals having difficulties reaching abstinence. Participants who fail to achieve smoking cessation during the quit period window will be referred for clinical treatment as desired in the center the study is conducted in or an alternative site.\n\nFollowing successful smoking abstinence at Week 0 (Week 0 is defined by 24 hr abstinence within a two-week grace period of the target date), participants will be randomized to the study drug condition (50 mg DCS or matching placebo) combined with cue-exposure therapy (CET). CET is manualized and will have four modalities: (1) exposure to slides of smoking (pictorial), (2) exposure to emotions and imagined situations that most reliably trigger an urge to smoke (emotional/imaginal), (3) exposure to a participant's own cigarettes and pack (in vivo),70 and (4) personalized and immersive 360° VR exposure (participants select the VR scene-e.g., break time outside work, evening party, car ride that best corresponds to their highest craving situation). CET sessions are scheduled for the quit week, one week later, and again 8 weeks later. Smoking cessation assessments continue across 24 weeks of follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (open phase)\n\n* daily smoker for at least one year, smoking an average of at least 10 cigarettes per day, and motivated to quit smoking (\\>5 on a 10 point scale)\n* had reactivity to in vivo smoking cues (an increase of two points or maximal score of 10 on a 10 point visual analogue craving scale \\[VAS\\]) following no smoking for a minimum of two hours\n* medical clearance to participate in the protocol\n\nExclusion Criteria:\n\n* use of other tobacco products\n* current unstable medical illness (i.e. deemed as at high risk of significant worsening by study intervention procedures by study physician; e.g. heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment), seizure disorder, pregnancy, breastfeeding, or use of isoniazid or ethionamide\n* lifetime history of psychotic disorders or uncontrolled bipolar disorder, by DSM-5 criteria as assessed by the MIni International Neuropsychiatric Interview\n* substance use disorder other than nicotine or caffeine active in the past 6 months, or excessive concurrent alcohol use as defined by self-report of an average of \\>21 standardized drinks per week for males or \\>14 standardized drinks per week for females\n* elevated suicide risk as determined by clinician interview\n* current use of any psychotropic medications or pharmacotherapy or psychotherapy for smoking cessation not provided by the investigators during the quit attempt\n* known hypersensitivity to DCS\n* insufficient command of the English language or inability to understand study procedures and participate in the informed consent process\n\nTo progress to the randomized phase:\n\n* participants must achieve a 24 hour abstinence period'}, 'identificationModule': {'nctId': 'NCT04035603', 'briefTitle': 'Multimodal Cue Exposure Therapy for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'Multimodal CET for Smoking Cessation Augmented With D-cycloserine', 'orgStudyIdInfo': {'id': 'R01DA048043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-Cycloserine Augmentation', 'description': 'D-cycloserine (DCS) augmentation of CET sessions', 'interventionNames': ['Drug: D-Cycloserine', 'Behavioral: Open Phase CBT that preceeds the randomization phase', 'Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Augmentation', 'description': 'Placebo (PBO) augmentation of CET sessions', 'interventionNames': ['Drug: Placebo oral tablet', 'Behavioral: Open Phase CBT that preceeds the randomization phase', 'Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phase']}], 'interventions': [{'name': 'D-Cycloserine', 'type': 'DRUG', 'otherNames': ['DCS'], 'description': '50 mg d-cycloserine given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment.', 'armGroupLabels': ['D-Cycloserine Augmentation']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'otherNames': ['PBO'], 'description': 'matching 50 mg identical placebo given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment.', 'armGroupLabels': ['Placebo Augmentation']}, {'name': 'Open Phase CBT that preceeds the randomization phase', 'type': 'BEHAVIORAL', 'description': 'Four sessions of weekly individual cognitive-behavior therapy (CBT: a form of psychotherapy that treats problems by helping people modify thoughts, behaviors, and emotions; in this case, for the goal of smoking cessation). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention).', 'armGroupLabels': ['D-Cycloserine Augmentation', 'Placebo Augmentation']}, {'name': 'Open phase smoking cessation pharmacotherapy that proceeds the randomization phase', 'type': 'DRUG', 'description': 'Initiating 2 weeks prior to quit date and continuing for 8 weeks after quit date, choice of one of three pharmacological smoking cessation aids: Nicotine Replacement Therapy (nicotine patch), Varenicline, or Bupropion.', 'armGroupLabels': ['D-Cycloserine Augmentation', 'Placebo Augmentation']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'One year after publication of primary aims', 'ipdSharing': 'YES', 'description': 'One year after publication of the primary aims from this project the primary and fully de-identified IPD will be made available by the investigators on CD for other researchers providing documented IRB consent from their institution.', 'accessCriteria': 'Institutional IRB approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael Otto', 'investigatorAffiliation': 'Boston University Charles River Campus'}}}}