Nicotine DependenceEarly Phase 1NCT03083353
Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
A Early Phase 1 study testing Isradipine and Cue Exposure in people with Nicotine Dependence and Smoking, Cigarette, run by Jasper A. Smits at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking, Cigarette, Smoking Cessation
- What is being tested?
- Isradipine and Cue Exposure
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 14 Jun 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence, Smoking, Cigarette, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Craving
- Being tested
- Isradipine, Cue Exposure
- Keywords
- nicotine, craving, virtual reality cue exposure, smoking relapse, immersive video environment, extinction enhancer
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Smoking Cessation, Smoking, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsradipineDrug
Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
Cue ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| isradipine | Experimental | Participants will receive 15mg of immediate release isradipine. Receives: Drug: Isradipine; Behavioral: Cue Exposure |
| placebo | Placebo comparator | Participants will receive a placebo pill identical in appearance to isradipine. Receives: Behavioral: Cue Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start22 Jan 2020
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive isradipine (ISR) or placebo (PBO).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper A. Smits
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Jasper A. Smits, University of Texas at Austin
- Investigators
- Cara C Young, Ph.D., Principal investigator, University of Texas at AustinJasper AJ Smits, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083353
- Sponsor's protocol ID
- 2016-09-0150
- Other IDs
- 1R21DA049539-01
- Status last verified
- May 2025
- First submitted
- 24 Feb 2017
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol files are available on the The Open Science Framework page for this project
Publications
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.
PubMed 38789642
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03083353
- Acronym / sponsor ID
- 2016-09-0150
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Jasper A. SmitsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive isradipine (ISR) or placebo (PBO).
| Arm | Type | Receives |
|---|---|---|
| isradipine | Experimental | Drug: Isradipine, Behavioral: Cue ExposureParticipants will receive 15mg of immediate release isradipine. |
| placebo | Placebo comparator | Behavioral: Cue ExposureParticipants will receive a placebo pill identical in appearance to isradipine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsradipineIsradipine will be administered 90 minutes prior to the initiation of cue exposure. | Drug | isradipine |
| Cue ExposureParticipants 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. | Behavioural | isradipine, placebo |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38789642Young 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.
- Individual participant dataSharing planned: Yes. Protocol files are available on the The Open Science Framework page for this project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara C Young, Ph.D. principal investigator
University of Texas at Austin
Jasper AJ Smits, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Isradipine and Cue Exposure in people with Nicotine Dependence and Smoking, Cigarette, run by Jasper A. Smits at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving Intensity to Smoking Cues (time frame: The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.