Clinical trial NCT03083353: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive isradipine (ISR) or placebo (PBO).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;
3. 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;
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.

Primary outcomes:
measure: Craving Intensity to Smoking Cues
timeFrame: The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Cara C Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Jasper AJ Smits, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: