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Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

Primary Purpose

Nicotine Dependence, Smoking, Cigarette, Smoking Cessation

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Isradipine

Cue Exposure

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine, craving, virtual reality cue exposure, smoking relapse, immersive video environment, extinction enhancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18-65 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.

Exclusion Criteria:

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;
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;
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.

Sites / Locations

University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

isradipine

placebo

Arm Description

Participants will receive 15mg of immediate release isradipine.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03083353

First Posted

February 24, 2017

Last Updated

October 31, 2022

Sponsor

University of Texas at Austin

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03083353

Brief Title

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

Official Title

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 22, 2020 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas at Austin

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

isradipine

Arm Type

Experimental

Arm Description

Participants will receive 15mg of immediate release isradipine.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Isradipine

Other Intervention Name(s)

DynaCirc, Prescal

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cue Exposure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Craving Intensity to Smoking Cues

Description

Primary outcome measures will be craving intensity to smoking cues based on a scale from 0 (No craving) to 100 (Intense craving).

Time Frame

The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-65 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. Exclusion Criteria: 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; 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alex (Research Coordinator)

Phone

512-471-1117

cravingresearch@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cara C Young, Ph.D.

Organizational Affiliation

University of Texas at Austin

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jasper AJ Smits, Ph.D.

Organizational Affiliation

University of Texas at Austin

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas at Austin

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alex (Research Coordinator)

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://osf.io/pk9yf/

Learn more about this trial

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

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