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 range18 Years – 65 Years
SexALL
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Inclusion criteria
âś“. 18-65 years old;
âś“. Willing and able to provide informed consent, attend all study visits, and comply with the protocol;
âś“. Daily smoker for at least one year; and
âś“. Currently smoke an average of at least 5 cigarettes per day.
Exclusion criteria
âś•. Current diagnosis of a psychotic, eating, developmental or bipolar disorder, or significant suicide risk;
âś•. Current treatment for smoking cessation or use of other nicotine products, including e-cigarettes;
âś•. 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;
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