TY - JOUR
T1 - Isradipine enhancement of virtual reality cue exposure for smoking cessation
T2 - Rationale and study protocol for a double-blind randomized controlled trial
AU - Papini, Santiago
AU - Young, Cara C.
AU - Gebhardt, Catherine S.
AU - Perrone, Alex
AU - Morikawa, Hitoshi
AU - Otto, Michael W.
AU - Roache, John D.
AU - Smits, Jasper A.J.
N1 - Funding Information:
This project was supported by NIH/NIDA 1R21DA049539-01 (MPI Young & Smits, Co[sbnd]I Papini). The National Institutes of Health had no role in the writing of the report or in the decision to submit the manuscript for publication.A. Perrone, C. Gebhardt, J. Roache, and C. Young report no conflict of interests with their funding. S. Papini receives support from the National Institutes of Health and the Donald D. Harrington Foundation. H. Morikawa receives support from the National Institutes of Health. M. Otto receives support from the National Institutes of Health and compensation as a speaker and Chair of the Scientific Advisory Board for Big Health. J. Smits receives support from the National Institutes of Health, compensation for his work as a consultant to Big Health, as editor for Elsevier and the American Psychological Association, and royalties from various book publishers. The authors declared that these funding organizations had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Funding Information:
A. Perrone, C. Gebhardt, J. Roache, and C. Young report no conflict of interests with their funding. S. Papini receives support from the National Institutes of Health and the Donald D. Harrington Foundation. H. Morikawa receives support from the National Institutes of Health . M. Otto receives support from the National Institutes of Health and compensation as a speaker and Chair of the Scientific Advisory Board for Big Health. J. Smits receives support from the National Institutes of Health , compensation for his work as a consultant to Big Health, as editor for Elsevier and the American Psychological Association , and royalties from various book publishers. The authors declared that these funding organizations had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Funding Information:
The study is funded by the National Institute on Drug Abuse (NIDA; 1R21DA049539-01) and is registered on clinicaltrials.gov (NCT03083353). Prior to acquisition of grant funding, an earlier version of the protocol was initiated under this trial registration but paused due to low recruitment (N = 7). The key changes to the protocol since funding acquisition are: an increase in participant compensation designed to increase recruitment, the addition of scenes to the virtual reality cue exposure protocol, and the addition of EMA data collection. The registration has been updated to reflect the procedures described below, which have been approved by the Institutional Review Board of the University of Texas at Austin. A Data Safety and Monitoring Board will oversee the study throughout the recruitment phase.
Funding Information:
This project was supported by NIH /NIDA 1R21DA049539-01 (MPI Young & Smits, Co I Papini). The National Institutes of Health had no role in the writing of the report or in the decision to submit the manuscript for publication.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/7
Y1 - 2020/7
N2 - Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. Toward this aim, the current protocol will apply a pharmacologic augmentation strategy informed by basic research in animal models of addiction. Our goal is to evaluate the enhancing effect of isradipine, an FDA-approved calcium channel blocker, on the extinction of craving—a key mechanism of drug relapse after periods of abstinence. To activate craving robustly in human participants, we will use multimodal smoking cues including novel 360° video environments developed for this project and delivered through consumer virtual reality headsets. Adult smokers will take either isradipine or placebo and complete the cue exposure protocol in a double-blind randomized control trial. In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo. The study will be implemented in a primary care setting where adult smokers receive healthcare, and smoking behavior will be tracked throughout the trial with ecological momentary assessment.
AB - Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. Toward this aim, the current protocol will apply a pharmacologic augmentation strategy informed by basic research in animal models of addiction. Our goal is to evaluate the enhancing effect of isradipine, an FDA-approved calcium channel blocker, on the extinction of craving—a key mechanism of drug relapse after periods of abstinence. To activate craving robustly in human participants, we will use multimodal smoking cues including novel 360° video environments developed for this project and delivered through consumer virtual reality headsets. Adult smokers will take either isradipine or placebo and complete the cue exposure protocol in a double-blind randomized control trial. In order to test the hypothesis that isradipine will enhance retention of craving extinction, participants will repeat cue exposure 24 h later without the administration of isradipine or placebo. The study will be implemented in a primary care setting where adult smokers receive healthcare, and smoking behavior will be tracked throughout the trial with ecological momentary assessment.
KW - Craving
KW - Extinction enhancer
KW - Immersive video environment
KW - Nicotine
KW - Smoking relapse
KW - Virtual reality cue exposure
UR - http://www.scopus.com/inward/record.url?scp=85085748297&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85085748297&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.106013
DO - 10.1016/j.cct.2020.106013
M3 - Article
C2 - 32335287
AN - SCOPUS:85085748297
SN - 1551-7144
VL - 94
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106013
ER -