Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083353
• Other study ID #: 2016-09-0150
• Secondary ID: 1R21DA049539-01
• Status: Completed
• Phase: Early Phase 1
• Start date: January 22, 2020
• Est. completion date: June 14, 2023

Study information

• Verified date: January 2024
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18-65 years old;

2. Willing and able to provide informed consent, attend all study visits, and comply with the protocol;

3. Daily smoker for at least one year; and

4. Currently smoke an average of at least 5 cigarettes per day.

Exclusion Criteria:

1. Current diagnosis of a psychotic, eating, developmental or bipolar disorder, or significant suicide risk;

2. Current treatment for smoking cessation or use of other nicotine products, including e-cigarettes;

3. Exclusion criteria related to isradipine administration: (a) known allergy or sensitivity to isradipine, (b) hypertension, (c) congestive heart failure, (d) any type of liver disease, (e) current pregnancy, (f) women of childbearing potential who are not using medically accepted forms of contraception, (g) current use of Rifampin, which decreases the availability of calcium channel blockers, or of Tagamet, which can increase hypotensive effects and inhibit hepatic metabolism of isradipine, (h) any other significant medical condition that increases risk, as determined by the study physician;

4. Significant vision problems that would prevent engagement with the 360° video environment; and

5. Past six month substance use disorder, other than nicotine use disorder, assessed by structured interview.

Related Conditions & MeSH terms

• Craving
• Nicotine Dependence
• Smoking Behaviors
• Smoking Cessation
• Smoking Reduction
• Smoking, Cigarette
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving Intensity to Smoking Cues	Primary outcome measures will be craving intensity to smoking cues based on a scale from 0 (No craving) to 100 (Intense craving).	The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration