Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

January 8, 2024 updated by: University of Texas at Austin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: isradipine
Participants will receive 15mg of immediate release isradipine.
Drug: Isradipine
Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
Other Names:
  • DynaCirc
  • Prescal
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.
Placebo Comparator: placebo
Participants will receive a placebo pill identical in appearance to isradipine.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craving Intensity to Smoking Cues
Time Frame: The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Cara C Young, Ph.D., University of Texas at Austin
  • Principal Investigator: Jasper AJ Smits, Ph.D., University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Actual)

June 14, 2023

Study Completion (Actual)

June 14, 2023

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-09-0150
  • 1R21DA049539-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol files are available on the The Open Science Framework page for this project: https://osf.io/pk9yf/

IPD Sharing Time Frame

Supporting information will be added as it becomes available.

IPD Sharing Access Criteria

Available files are stored on the The Open Science Framework page for this project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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