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Isradipine for Smoking

Phase < 1
Waitlist Available
Led By Jasper AJ Smits, Ph.D.
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
Awards & highlights

Study Summary

This trial is important because it could lead to a more effective treatment for smokers who are trying to quit.

Eligible Conditions
  • Smoking
  • Craving
  • Smoking/Cigarette Smoking
  • Smoking Cessation
  • Nicotine Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome is measured in a medication-free cue exposure session conducted 24 hours after medication administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Craving Intensity to Smoking Cues

Side effects data

From 2018 Phase 3 trial • 336 Patients • NCT02168842
25%
DIZZINESS
18%
OEDEMA
16%
HEADACHE
15%
NAUSEA
14%
NASOPHARYNGITIS
14%
FATIGUE
14%
CONSTIPATION
12%
ANXIETY
12%
DEPRESSION
11%
INSOMNIA
10%
ARTHRALGIA
10%
BACK PAIN
7%
UPPER RESPIRATORY TRACT INFECTION
7%
MUSCULOSKELETAL PAIN
7%
JOINT SWELLING
6%
PAIN IN EXTREMITY
6%
SOMNOLENCE
6%
MUSCLE SPASMS
5%
HYPOAESTHESIA
5%
COUGH
5%
MUSCULOSKELETAL STIFFNESS
5%
DYSTONIA
5%
DYSPNOEA
5%
HYPERTENSION
5%
SLEEP DISORDER
4%
ABDOMINAL PAIN UPPER
4%
SINUSITIS
4%
CHEST PAIN
4%
MYALGIA
4%
MICTURITION URGENCY
4%
FLUSHING
4%
VISION BLURRED
4%
RAPID EYE MOVEMENTS SLEEP ABNORMAL
4%
TENDONITIS
4%
OSTEOARTHRITIS
4%
MUSCLE STRAIN
4%
RASH
4%
PALPITATIONS
4%
DIARRHOEA
4%
BLOOD CREATINE PHOSPHOKINASE INCREASED
4%
BASAL CELL CARCINOMA
4%
DYSPHAGIA
4%
FALL
4%
POLLAKIURIA
4%
ERECTILE DYSFUNCTION
4%
BLOOD CREATININE INCREASED
3%
HOT FLUSH
3%
PAIN
3%
BENIGN PROSTATIC HYPERPLASIA
3%
NEPHROLITHIASIS
3%
CONFUSIONAL STATE
3%
GASTROOESOPHAGEAL REFLUX DISEASE
3%
ROTATOR CUFF SYNDROME
3%
DIVERTICULITIS
3%
BRONCHITIS
3%
ORTHOSTATIC HYPOTENSION
3%
LACERATION
3%
PARAESTHESIA
3%
URINARY TRACT INFECTION
3%
TREMOR
2%
SCIATICA
2%
RESTLESS LEGS SYNDROME
2%
DYSPEPSIA
2%
NASAL CONGESTION
2%
BRADYKINESIA
2%
RHINORRHOEA
2%
URINARY INCONTINENCE
2%
ALOPECIA
2%
RESPIRATORY TRACT INFECTION
2%
VOMITING
2%
OSTEOPOROSIS
2%
EAR DISCOMFORT
2%
MUSCULAR WEAKNESS
2%
SALIVARY HYPERSECRETION
2%
SYNCOPE
2%
TACHYCARDIA
2%
INFLUENZA
2%
ABDOMINAL DISTENSION
2%
VITAMIN D DEFICIENCY
2%
ABDOMINAL PAIN
2%
TOOTH ABSCESS
2%
HYPOTENSION
2%
DRY EYE
2%
SQUAMOUS CELL CARCINOMA
2%
DRY MOUTH
2%
AMNESIA
2%
DECREASED APPETITE
2%
CATARACT
2%
INGUINAL HERNIA
2%
ABNORMAL LOSS OF WEIGHT
2%
LOWER RESPIRATORY TRACT INFECTION
2%
ABNORMAL DREAMS
2%
EYE INFECTION
2%
SUICIDAL IDEATION
2%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
1%
HALLUCINATION
1%
COGNITIVE DISORDER
1%
HERPES ZOSTER
1%
ERYTHEMA
1%
APPENDICEAL MUCOCOELE
1%
BRADYCARDIA
1%
PROTEINURIA
1%
LIGAMENT SPRAIN
1%
PANCREATIC NEOPLASM
1%
SMALL INTESTINAL OBSTRUCTION
1%
ANAEMIA
1%
HYPERGLYCAEMIA
1%
URINARY RETENTION
1%
ATRIAL FIBRILLATION
1%
DEEP VEIN THROMBOSIS
1%
PLANTAR FASCIITIS
1%
PULMONARY MASS
1%
TRANSIENT ISCHAEMIC ATTACK
1%
EPISTAXIS
1%
GASTROINTESTINAL HAEMORRHAGE
1%
INTRAVENTRICULAR HAEMORRHAGE
1%
GASTROENTERITIS VIRAL
1%
ASTHENIA
1%
MEMORY IMPAIRMENT
1%
SEPSIS
1%
COLON CANCER
1%
ARTHRITIS
1%
STRESS FRACTURE
1%
PROSTATE CANCER
1%
UPPER LIMB FRACTURE
1%
CHOROID MELANOMA
1%
CHEST DISCOMFORT
1%
ISCHAEMIC STROKE
1%
SPINA BIFIDA
1%
PNEUMONIA ASPIRATION
1%
SPINAL FRACTURE
1%
THROAT CANCER
1%
CONTUSION
1%
IRRITABILITY
1%
VERTIGO
1%
WRIST FRACTURE
1%
PNEUMONIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (for Isradipine)
Isradipine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: isradipineExperimental Treatment2 Interventions
Participants will receive 15mg of immediate release isradipine.
Group II: placeboPlacebo Group1 Intervention
Participants will receive a placebo pill identical in appearance to isradipine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cue Exposure
2020
Completed Early Phase 1
~80
Isradipine
2006
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,515 Total Patients Enrolled
67 Trials studying Smoking
22,620 Patients Enrolled for Smoking
University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
80,906 Total Patients Enrolled
2 Trials studying Smoking
621 Patients Enrolled for Smoking
Jasper AJ Smits, Ph.D.Principal InvestigatorUniversity of Texas at Austin

Media Library

Cue Exposure Clinical Trial Eligibility Overview. Trial Name: NCT03083353 — Phase < 1
Smoking Research Study Groups: isradipine, placebo
Smoking Clinical Trial 2023: Cue Exposure Highlights & Side Effects. Trial Name: NCT03083353 — Phase < 1
Cue Exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT03083353 — Phase < 1
Smoking Patient Testimony for trial: Trial Name: NCT03083353 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study accept participants aged forty and above?

"The inclusion criteria for this study stipulate that participants must be at least 18 years old and no older than 65."

Answered by AI

Are opportunities to join this experiment still available?

"Affirmative. Research listed on clinicaltrials.gov supports that this study, whose commencement was January 22nd 2020, is currently recruiting patients. 102 individuals are required to join at a single site."

Answered by AI

What criteria must a participant fulfill to join this research project?

"To be a successful applicant, potential participants must have tobacco-using habits and fall between 18 to 65 years of age. This study has the capacity for 102 individuals in total."

Answered by AI

How many participants are being inducted into this research program?

"Affirmative. The information presented on clinicaltrials.gov reveals this medical experiment is currently enrolling subjects, with an initial posting date of January 22nd 2020 and the most recent update being October 31st 2022. This trial requires 102 individuals to be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
What site did they apply to?
University of Texas at Austin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+

What questions have other patients asked about this trial?

How long is each visit? Is there compensation for the trial? What is the length? How many visits?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I've tried patches, pills, gum, everything. I want to quit and if this will help me it could help others quit as well.
PatientReceived 2+ prior treatments
I have been a smoker for 35 years and have tried many times to quit. I know the impact it has on my health and would be grateful for any tools that help me achieve that goal.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
2020. "Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03083353.
~15 spots leftby Apr 2025
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