Trial Outcomes & Findings for Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation (NCT NCT03083353)
NCT ID: NCT03083353
Last Updated: 2025-06-15
Results Overview
Primary outcome measures will be craving intensity to smoking cues based on a scale from 0 (No craving) to 100 (Intense craving).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
78 participants
Primary outcome timeframe
The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
Results posted on
2025-06-15
Participant Flow
Participants were recruited from January 2020 to June 2023 with a pause from March 2020 to December 2020 resulting from pandemic-related restrictions on research
To be eligible for randomization, individuals had to abstain from smoking, starting 24 hours prior to the treatment visit. Prior to randomization at the treatment visit, individuals who reported smoking or had carbon monoxide level that exceeded 4 ppm were ineligible to participate that day but could reschedule.
Participant milestones
| Measure |
Isradipine
Participants will receive 15mg of immediate release isradipine.
Isradipine: Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
Cue Exposure: 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.
|
Placebo
Participants will receive a placebo pill identical in appearance to isradipine.
Cue Exposure: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Isradipine
n=40 Participants
Participants will receive 15mg of immediate release isradipine.
Isradipine: Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
Cue Exposure: 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.
|
Placebo
n=38 Participants
Participants will receive a placebo pill identical in appearance to isradipine.
Cue Exposure: 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.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.10 years
STANDARD_DEVIATION 12.14 • n=5 Participants
|
44.76 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
42.88 years
STANDARD_DEVIATION 11.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Education level
Graduate School
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education level
College Graduate
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Education level
Partial College
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education level
High School Graduate
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education level
Partial High School
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Years of daily smoking
|
20.53 years
STANDARD_DEVIATION 12.23 • n=5 Participants
|
23.42 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
21.94 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Craving intensity to smoking cues
|
51.13 units on a scale
STANDARD_DEVIATION 3.73 • n=5 Participants
|
60.39 units on a scale
STANDARD_DEVIATION 3.83 • n=7 Participants
|
55.76 units on a scale
STANDARD_DEVIATION 3.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: The outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administrationPrimary outcome measures will be craving intensity to smoking cues based on a scale from 0 (No craving) to 100 (Intense craving).
Outcome measures
| Measure |
Isradipine
n=40 Participants
Participants will receive 15mg of immediate release isradipine.
Isradipine: Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
Cue Exposure: 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.
|
Placebo
n=38 Participants
Participants will receive a placebo pill identical in appearance to isradipine.
Cue Exposure: 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.
|
|---|---|---|
|
Craving Intensity to Smoking Cues
|
40.50 units on a scale
Standard Error 3.54
|
50.44 units on a scale
Standard Error 3.59
|
Adverse Events
Isradipine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Isradipine
n=40 participants at risk
Participants will receive 15mg of immediate release isradipine.
Isradipine: Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
Cue Exposure: 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.
|
Placebo
n=38 participants at risk
Participants will receive a placebo pill identical in appearance to isradipine.
Cue Exposure: 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.
|
|---|---|---|
|
General disorders
Headache
|
27.5%
11/40 • Number of events 11 • 48 hours
Adverse events were collected during session 1 and session 2.
|
7.9%
3/38 • Number of events 3 • 48 hours
Adverse events were collected during session 1 and session 2.
|
|
Cardiac disorders
Heart racing
|
5.0%
2/40 • Number of events 2 • 48 hours
Adverse events were collected during session 1 and session 2.
|
0.00%
0/38 • 48 hours
Adverse events were collected during session 1 and session 2.
|
|
Gastrointestinal disorders
Upset stomach
|
5.0%
2/40 • Number of events 2 • 48 hours
Adverse events were collected during session 1 and session 2.
|
0.00%
0/38 • 48 hours
Adverse events were collected during session 1 and session 2.
|
|
General disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • 48 hours
Adverse events were collected during session 1 and session 2.
|
0.00%
0/38 • 48 hours
Adverse events were collected during session 1 and session 2.
|
|
General disorders
Discomfort with virtual reality protocol
|
0.00%
0/40 • 48 hours
Adverse events were collected during session 1 and session 2.
|
2.6%
1/38 • Number of events 1 • 48 hours
Adverse events were collected during session 1 and session 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place