Beta-Adrenergic Modulation of Drug Cue Reactivity

NCT ID: NCT05587361

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2026-03-01

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.

Detailed Description

Cigarette use remains a serious public health problem in the United States and worldwide. Effective pharmacological interventions for smoking cessation exist, but these medications primarily target nicotine withdrawal and smoking reinforcement. The cues and contexts associated with smoking also play an important role in driving smoking behavior, but evidence is extremely mixed whether existing interventions can effectively attenuate smoking urges and behavior in response to these cues and contexts.

In a previous pilot trial, the investigators demonstrated that propranolol suppressed smoking cue reactivity and brain activation across a constellation of brain regions implicated in nicotine dependence. Here, the investigators seek to extend this work by examining effects when the drug is administered in combination with an established treatment targeting withdrawal and reinforcement (i.e., nicotine patch).

Following consent and screening/baseline activities, participants will attend four neuroimaging appointments each lasting approximately 5 hours. Participants will be fitted with a nicotine or placebo patch, fed a standard meal and then administered propranolol or placebo. Participants will complete questionnaires and have their heart rate/blood pressure monitored throughout the visit. During the MRI scan, participants will be asked to complete both resting scans and task-based scans during which participants will view images of smoking and non-smoking objects and scenes.

Conditions

Tobacco Use Disorder; Nicotine Dependence; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo Patch/Placebo Propranolol

Placebo Nicotine Patch Placebo Propranolol

Group Type: PLACEBO_COMPARATOR

Placebo Propranolol

Intervention Type: DRUG

Placebo Capsule, no active ingredients

Placebo Patch

Intervention Type: DRUG

Placebo Patch, no active ingredients

Placebo Patch/Active Propranolol

Placebo Nicotine Patch Active Propranolol (40 mg, immediate release)

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Propranolol Capsule; 40 mg IR

Placebo Patch

Intervention Type: DRUG

Placebo Patch, no active ingredients

Active Patch/Placebo Propranolol

Active Nicotine Patch (14 mg) Placebo Propranolol

Group Type: EXPERIMENTAL

Nicotine Patch

Intervention Type: DRUG

Nicotine Patch; 14 mg

Placebo Propranolol

Intervention Type: DRUG

Placebo Capsule, no active ingredients

Active Patch/Active Propranolol

Active Nicotine Patch (14 mg) Active Propranolol (40 mg, immediate release)

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Propranolol Capsule; 40 mg IR

Nicotine Patch

Intervention Type: DRUG

Nicotine Patch; 14 mg

Interventions

Propranolol

Propranolol Capsule; 40 mg IR

Intervention Type: DRUG

Nicotine Patch

Nicotine Patch; 14 mg

Intervention Type: DRUG

Placebo Propranolol

Placebo Capsule, no active ingredients

Intervention Type: DRUG

Placebo Patch

Placebo Patch, no active ingredients

Intervention Type: DRUG

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason A Oliver, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason A Oliver, PhD

Role: CONTACT

Jason-Oliver@ouhsc.edu

405-271-8001 ext. 14005

Isabel Brush, B.A.

Role: CONTACT

Isabel-Brush@ouhsc.edu

Facility Contacts

Isabel Brush, B.A.

Role: primary

Isabel-Brush@ouhsc.edu

Rebecca Gonzalez, B.A.

Role: backup

Rebecca-Gonzalez@ouhsc.edu

Other Identifiers

1R01DA053342-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022005-OSU-CHS

Identifier Type: -

Identifier Source: org_study_id