Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation (NCT03083353) | Clinical Trial Compass
CompletedEarly Phase 1
Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
United States78 participantsStarted 2020-01-22
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined a blood pressure medication called isradipine with virtual reality cue exposure therapy — can you explain how each of those two components was supposed to help reduce cigarette cravings, and whether that approach has moved into later-stage testing?
2Since this was an early Phase 1 study primarily measuring craving intensity rather than actual quit rates, what do we know so far about whether reducing cue-triggered cravings in a lab setting actually translates to quitting success in real life?
3Given that the trial is now completed, has any data been published yet showing whether isradipine appeared safe and tolerable for smokers in this context, and are there any side effects from isradipine I should be aware of if this kind of approach ever becomes available to me?
4Compared to this experimental combination approach, how do currently approved smoking cessation treatments like varenicline or nicotine replacement therapy stack up, and should I try those first before considering newer experimental options?
5Are there any follow-up or Phase 2 trials building on this study's results that you might think are worth looking into, given my specific situation with nicotine dependence?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Craving Intensity to Smoking Cues
Timeframe: The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
. 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.