NCT05587361 Beta-Adrenergic Modulation of Drug Cue Reactivity
| NCT ID | NCT05587361 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Oklahoma |
| Condition | Tobacco Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2024-11-26 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.
Eligibility Criteria
Inclusion Criteria: 1. Generally healthy 2. Age 21-60 3. Right-handed using a three-item scale 4. Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC) 5. Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months 6. Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and/or morning urinary cotinine \>100 ng/ml 7. Must identity at least 4 different smoking locations used in a typical week 8. Able to read and understand English Exclusion Criteria: 1. Inability to attend all required sessions 2. Significant health problems that would preclude active participation 3. Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape) 4. Current use of psychoactive medications/drugs as indicated by self-report or urine screen 5. Positive breath alcohol concentration 6. Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females) 7. Problems with vision that cannot be corrected with contacts or glasses 8. Current regular use of smokeless tobacco, smoking cessation medications, or other nicotine containing products (e.g. electronic cigarettes) 9. Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications 10. Systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg (sitting or standing) 11. Abnormal EKG 12. Presence of severe anemia 13. Presence of electrolyte imbalance that could impact blood pressure 14. Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)
Contact & Investigator
Jason A Oliver, PhD
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05587361 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Tobacco Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05587361 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05587361 currently recruiting?
Yes, NCT05587361 is actively recruiting participants. Contact the research team at Jason-Oliver@ouhsc.edu for enrollment information.
Where is the NCT05587361 trial being conducted?
This trial is being conducted at Tulsa, United States.
Who is sponsoring the NCT05587361 clinical trial?
NCT05587361 is sponsored by University of Oklahoma. The principal investigator is Jason A Oliver, PhD at University of Oklahoma. The trial plans to enroll 80 participants.