Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2023-06-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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isradipine

Participants will receive 15mg of immediate release isradipine.

Group Type EXPERIMENTAL

Isradipine

Intervention Type DRUG

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

Cue Exposure

Intervention Type 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.

placebo

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

Group Type PLACEBO_COMPARATOR

Cue Exposure

Intervention Type 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.

Interventions

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Isradipine

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes