Cognitive Remediation With D-Cycloserine
One hundred eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria, and demonstrate response to cue reactivity at the screening visit, will either be:
- started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which method to use to quit smoking will be based on participant choice as well as taking into account any medical contraindications to either therapy.
- evaluated to confirm abstinence from smoking. Recently abstinent participants referred by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm to confirm abstinence.
Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study involves twelve visits and will last approximately ten weeks. For recently abstinent participants referred by a smoking cessation clinic, PCP or self referred, the study involves 7 visits (screening and baseline visit will be merged into one and there is no CBT component) and will last approximately 7 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Cognitive Remediation With D-cycloserine to Improve Smoking Cessation Outcomes|
- Effect of D-cycloserine + cue-exposure treatment on physiologic reactivity (skin conductance, Heart rate, electromyogram), attentional bias and craving in response to smoking cues [ Time Frame: It will be measured once during the study, at visit 11 (study week 10) after two sessions of cue exposure treatment ] [ Designated as safety issue: No ]Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate, skin conductance and EMG) reactivity to smoking cues, less craving and less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||Drug: Placebo|
|Active Comparator: D-cycloserine||
2 single weekly doses, 50 mg capsule
|Contact: Heather Burrell, BAemail@example.com|
|Contact: Gladys Pachas, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital - Center For Addiction Medicine||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Heather Burrell, BA 617-643-4691 email@example.com|
|Sub-Investigator: Gladys N Pachas, MD|
|Sub-Investigator: Michael Otto, PhD|
|Sub-Investigator: Corinne Cather, PhD|
|Principal Investigator:||A. Eden Evins, MD, MPH||Massachusetts General Hospital|