Status:
COMPLETED
Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The central objective of this project is to obtain proof-of-concept data demonstrating the effects of propranolol (a beta-adrenergic antagonist) on neurobiological responses to personal smoking enviro...
Eligibility Criteria
Inclusion
- Between the ages of 18 and 55
- Generally healthy
- Right-handed
- Smoke \>= 5 cigarettes/day of a brand delivering 0.5 mg nicotine (FTC method)
- Have been smoking regularly for \>= 1 year, with a stable smoking pattern over the past 6 months
- Have an expired CO concentration of \>= 10 ppm or urinary cotinine \> 100 ng/ml
- Are able to identify at least 4 smoking and 4 non-smoking enviornments
Exclusion
- Inability to attend all required sessions
- Significant health problems that would interfere with completion of study procedures
- Presence of conditions that would make MRI unsafe (e.g. pacemaker)
- Presence of exclusionary psychopathology based on MINI interview (current alcohol/substance use disorder moderate or severe pmild is allowable\], any history of bipolar disorder or psychosis). Individuals in early remission from substance use disorder (not in a controlled environment) may also be allowed at the PIs discretion
- Current use of psychoactive medications per self-report or urine screen. Certain prescribed medications are allowable at the PI's discretion if appropriate documentation (e.g. copy of prescription or physician letter) is provided
- Positive breath alcohol concentraiton Pregnant, breastfeeding, or planning to become pregnant during the course of study
- Problems with vision that cannot be corrected with contacts or glasses
- Current regular use of smokeless tobacco, smoking cessation medications or non-combustible nicotine products (e.g. e-cigarettes)
- Plans to alter smoking pattern (e.g. reduction, uptake, cessation) during course of study
- Current use of beta-adrenergic medication
- Systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg (sitting or standing)
- Low resting heart rate (\< 60 beats per minute)
- Abnormal EKG
- Presence of severe anemia (per complete blood count)
- Presence of electrolyte imbalance that could impact blood pressure (per metabolic panel)
- Presence of any other contraindications for propranolol (e.g. cardiovascular disease, bronchial asthma, prior allergic reaction)
- Note that the above criteria reflect general guidelines for decision-making, but ultimate determinations are left to the discretion of the study physician. Presence of minor (e.g. asymptomatic bradycardia in the range of 50-60 in an otherwise healthy adult) or transient (e.g. electrolyte imbalance readily addressed via changes in fluid intake) may still be deemed eligible to participate.
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03309943
Start Date
January 16 2018
End Date
July 15 2019
Last Update
August 13 2020
Active Locations (1)
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1
Duke University School of Medicine
Durham, North Carolina, United States, 27705