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New treatment option for Tobacco Use Disorder
Official title Beta-Adrenergic Modulation of Drug Cue Reactivity
ClinicalTrials.gov ID: NCT05587361
What this study is testing
What is Propranolol?
Propranolol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for tobacco use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Generally healthy
- Age 21-60
- Right-handed using a three-item scale
- Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
- Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months
You likely can't join if
- Inability to attend all required sessions
- Significant health problems that would preclude active participation
- Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)
- Current use of psychoactive medications/drugs as indicated by self-report or urine screen
- Positive breath alcohol concentration
- Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)
See the full eligibility criteria
- Generally healthy
- Age 21-60
- Right-handed using a three-item scale
- Daily smoker of ≥ 5 cigarettes/day delivering 0.5 mg nicotine (FTC)
- Smoking regularly for ≥ 1 year, with stable smoking for the past 6 months
- Afternoon expired Carbon Monoxide (CO) concentration ≥ 6 ppm and/or morning urinary cotinine \>100 ng/ml
- Must identity at least 4 different smoking locations used in a typical week
- Able to read and understand English
- Inability to attend all required sessions
- Significant health problems that would preclude active participation
- Presence of conditions that would make MRI unsafe (e.g. pacemaker) or (e.g. weight and body shape)
- Current use of psychoactive medications/drugs as indicated by self-report or urine screen
- Positive breath alcohol concentration
- Pregnant, breastfeeding, or planning to become pregnant during the course of the study (females)
- Problems with vision that cannot be corrected with contacts or glasses
- Current regular use of smokeless tobacco, smoking cessation medications, or other nicotine containing products (e.g. electronic cigarettes)
- Current use of beta-adrenergic medications (e.g. beta-blockers) or other blood pressure medications
- Systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg (sitting or standing)
- Abnormal EKG
- Presence of severe anemia
- Presence of electrolyte imbalance that could impact blood pressure
- Presence of any other contraindications for propranolol or nicotine patch (e.g. cardiovascular disease, bronchial asthma, prior allergic reactions, diabetes)
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.