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Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

NCT03083353 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-06-15

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Cara C Young, Ph.D. · University of Texas at Austin

  • Jasper AJ Smits, Ph.D. · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2023-06-14
Completion
2023-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083353 on ClinicalTrials.gov