NCT04035603

Multimodal Cue Exposure Therapy for Smoking Cessation

Multimodal CET for Smoking Cessation Augmented With D-cycloserine

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston University Charles River Campus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 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. Following 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	D-Cycloserine	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.
DRUG	Placebo oral tablet	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.
BEHAVIORAL	Open Phase CBT that preceeds the randomization phase	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).
DRUG	Open phase smoking cessation pharmacotherapy that proceeds the randomization phase	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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-07-29
• Last updated: 2021-02-12