Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas at Austin
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Isradipine

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.