Multimodal Cue Exposure Therapy for Smoking Cessation

• Status: Withdrawn
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University Charles River Campus
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cycloserine

Criteria

Inclusion Criteria: (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 Criteria:

• 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