Status:
WITHDRAWN
Multimodal Cue Exposure Therapy for Smoking Cessation
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- (open phase)
- 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)
- 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
- medical clearance to participate in the protocol
Exclusion
- use of other tobacco products
- 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
- lifetime history of psychotic disorders or uncontrolled bipolar disorder, by DSM-5 criteria as assessed by the MIni International Neuropsychiatric Interview
- 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
- elevated suicide risk as determined by clinician interview
- current use of any psychotropic medications or pharmacotherapy or psychotherapy for smoking cessation not provided by the investigators during the quit attempt
- known hypersensitivity to DCS
- insufficient command of the English language or inability to understand study procedures and participate in the informed consent process
- To progress to the randomized phase:
- participants must achieve a 24 hour abstinence period
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04035603
Start Date
October 1 2020
End Date
January 31 2021
Last Update
February 12 2021
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