RECRUITING

Beta-Adrenergic Modulation of Drug Cue Reactivity

Conditions

Tobacco Use Disorder Nicotine Dependence Cigarette Smoking

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Beta-Adrenergic Modulation of Drug Cue Reactivity: Neural and Behavioral Mechanisms

Quick Facts

Study Start:2024-11-20

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05587361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Jason A Oliver, PhD

CONTACT

405-271-8001

Jason-Oliver@ouhsc.edu

Isabel Brush, B.A.

CONTACT

Isabel-Brush@ouhsc.edu

Principal Investigator

Jason A Oliver, PhD

PRINCIPAL_INVESTIGATOR

University of Oklahoma

Study Locations (Sites)

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, 74136

United States

Collaborators and Investigators

Sponsor: University of Oklahoma

Jason A Oliver, PhD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2024-11-20

Study Completion Date2025-03-30

Terms related to this study

Additional Relevant MeSH Terms

Tobacco Use Disorder
Nicotine Dependence
Cigarette Smoking