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Propranolol + Nicotine Patch for Smoking Addiction

Phase 4
Recruiting
Led By Jason A Oliver, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4-5 hours
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial looks at how a drug and nicotine patch affect the brain and behavior when exposed to smoking cues. It's a short-term experiment in humans with no quit attempt.

Who is the study for?
This trial is for English-speaking, right-handed adults aged 21-60 who have been smoking regularly for at least a year. Participants should smoke over 5 cigarettes daily and be generally healthy. Exclusions include low blood pressure, use of psychoactive drugs or certain medications, pregnancy, abnormal EKG results, severe anemia or electrolyte issues, MRI safety risks like pacemakers, vision problems uncorrectable with glasses/contacts, and significant health conditions.
What is being tested?
The study tests the effects of Propranolol (a beta-blocker) and nicotine patches on smokers' reactions to cues that make them want to smoke. It's not a long-term treatment test but looks at immediate responses in controlled settings. Participants will receive either the actual drugs or placebos in various combinations.
What are the potential side effects?
Propranolol can cause dizziness due to lowered blood pressure, fatigue, trouble sleeping and may worsen asthma symptoms. Nicotine patches might lead to skin irritation where applied, sleep disturbances including vivid dreams or insomnia and muscle aches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4-5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4-5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Association between Smoking Urge and Brain Activation
Brain
Oxygen saturation measurement
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo Patch/Active PropranololExperimental Treatment2 Interventions
Placebo Nicotine Patch Active Propranolol (40 mg, immediate release)
Group II: Active Patch/Placebo PropranololExperimental Treatment2 Interventions
Active Nicotine Patch (14 mg) Placebo Propranolol
Group III: Active Patch/Active PropranololExperimental Treatment2 Interventions
Active Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release)
Group IV: Placebo Patch/Placebo PropranololPlacebo Group2 Interventions
Placebo Nicotine Patch Placebo Propranolol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Propranolol
2019
Completed Phase 1
~60
Propranolol
2010
Completed Phase 4
~1290
Nicotine Patch
2011
Completed Phase 4
~10480
Placebo Patch
2011
Completed Phase 4
~4500

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,611 Total Patients Enrolled
5 Trials studying Tobacco Use Disorder
660 Patients Enrolled for Tobacco Use Disorder
Oklahoma State University Center for Health SciencesOTHER
35 Previous Clinical Trials
4,820 Total Patients Enrolled
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,981,467 Total Patients Enrolled
28 Trials studying Tobacco Use Disorder
5,127 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,735 Total Patients Enrolled
281 Trials studying Tobacco Use Disorder
49,157 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,153 Total Patients Enrolled
46 Trials studying Tobacco Use Disorder
26,171 Patients Enrolled for Tobacco Use Disorder
Jason A Oliver, PhDPrincipal InvestigatorUniversity of Oklahoma
2 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Active Patch/Active Propranolol Clinical Trial Eligibility Overview. Trial Name: NCT05587361 — Phase 4
Tobacco Use Disorder Research Study Groups: Placebo Patch/Placebo Propranolol, Placebo Patch/Active Propranolol, Active Patch/Placebo Propranolol, Active Patch/Active Propranolol
Tobacco Use Disorder Clinical Trial 2023: Active Patch/Active Propranolol Highlights & Side Effects. Trial Name: NCT05587361 — Phase 4
Active Patch/Active Propranolol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587361 — Phase 4
~40 spots leftby Mar 2025
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