Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

NCT03083353 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2016-09-01501R21DA049539-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nicotine; craving; virtual reality cue exposure; smoking relapse; immersive video environment; extinction enhancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

isradipine

EXPERIMENTAL

Participants will receive 15mg of immediate release isradipine.

Drug: Isradipine; Behavioral: Cue Exposure

placebo

PLACEBO COMPARATOR

Participants will receive a placebo pill identical in appearance to isradipine.

Behavioral: Cue Exposure

Interventions

Isradipine DRUG

Isradipine will be administered 90 minutes prior to the initiation of cue exposure.

isradipine

Cue Exposure BEHAVIORAL

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.

isradipine; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Willing and able to provide informed consent, attend all study visits, and comply with the protocol;
• Daily smoker for at least one year; and
• Currently smoke an average of at least 5 cigarettes per day.

You may not qualify if:

• Current diagnosis of a psychotic, eating, developmental or bipolar disorder, or significant suicide risk;
• Current treatment for smoking cessation or use of other nicotine products, including e-cigarettes;
• Significant vision problems that would prevent engagement with the 360° video environment; and
• Past six month substance use disorder, other than nicotine use disorder, assessed by structured interview.

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Young CC, Papini S, Minami H, Morikawa H, Otto MW, Roache JD, Smits JAJ. Isradipine augmentation of virtual reality cue exposure therapy for tobacco craving: a triple-blind randomized controlled trial. Neuropsychopharmacology. 2024 Oct;49(11):1711-1718. doi: 10.1038/s41386-024-01872-9. Epub 2024 May 24.

  PMID: 38789642 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Smoking Cessation; Smoking; Smoking Reduction

Interventions

Isradipine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sara Reedy
• Organization: The University of Texas at Austin

Sarah.Fella@austin.utexas.edu

512-232-4319

Study Officials

• Cara C Young, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Jasper AJ Smits, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study capsules will be prepared containing: (a) 15 mg immediate release isradipine or (b) pill placebo consisting of Avicel microcrystalline cellulose powder (non-digestible pass-through). Isradipine and placebo capsules will be identical in appearance to maintain the double-blind. Individual doses will be dispensed to participants by blinded personnel 75 m prior to the first cue exposure session and patients will be asked to remain in the clinic until session time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive isradipine (ISR) or placebo (PBO).

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 20, 2017
• Study Start: January 22, 2020
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting information will be added as it becomes available.
• Access Criteria: Available files are stored on the The Open Science Framework page for this project.

Locations

US (1)