NCT03083353

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The proposed study represents a crucial and important stage in translating basic research to strategies for treating nicotine dependence. The investigation addresses an important public health issue by testing an intervention - informed by basic research - that may lead to a more effective and efficient treatment for smokers. The expected findings should provide initial effect size data for the addition of isradipine to an integrated psychosocial/behavioral and pharmacological smoking cessation intervention for smokers, and thus provide the necessary data for a large-scale follow-up trial.

Detailed description

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 in a medication-free state 24 h later. 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.

Conditions

• Nicotine Dependence
• Smoking, Cigarette
• Smoking Cessation
• Smoking Behaviors
• Smoking Reduction
• Craving

Interventions

Type	Name	Description
DRUG	Isradipine	Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
BEHAVIORAL	Cue Exposure	Participants will be exposed to visual smoking cues (i.e., immersive 360 degree video environments) delivered through consumer virtual reality headset and handle cigarette packs to activate and extinguish craving.

Timeline

• Start date: 2020-01-22
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2017-03-20
• Last updated: 2025-06-15
• Results posted: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study