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Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083353
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Smoking, Cigarette Smoking Cessation Smoking Behaviors Smoking Reduction Craving Drug: Isradipine Behavioral: Cue Exposure Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive isradipine (ISR) or placebo (PBO).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Isradipine

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 VR 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 VR headset and handle cigarette packs to activate and extinguish craving.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083353


Contacts
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Contact: Alex (Research Coordinator) 512-471-1117 cravingresearch@gmail.com

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Alex (Research Coordinator)         
Sponsors and Collaborators
University of Texas at Austin
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Cara C Young, Ph.D. University of Texas at Austin
Principal Investigator: Jasper AJ Smits, Ph.D. University of Texas at Austin
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03083353    
Other Study ID Numbers: 2016-09-0150
1R21DA049539-01 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocol files are available on the OSF page for this project: https://osf.io/pk9yf/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Supporting information will be added as it becomes available.
Access Criteria: Available files are stored on the OSF page for this project.
URL: https://osf.io/pk9yf/

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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
Keywords provided by University of Texas at Austin:
nicotine
craving
virtual reality cue exposure
smoking relapse
immersive video environment
extinction enhancer
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Isradipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents