Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity

NCT ID: NCT03309943

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-16
• Study Completion Date: 2019-07-15

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 environments and behavioral responses in a laboratory smoking behavior task. Human cigarette smokers (N = 50) will take photographs of locations where they do and do not smoke cigarettes. They will then be randomly assigned to receive either propranolol (40 mg) or placebo prior to completing: A) An MRI session assessing neural responses to personal smoking/non-smoking environments, standard smoking/non-smoking environments and proximal smoking/non-smoking cues; and B) A laboratory session examining smoking behavior in response to environmental cues.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Propranolol

Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

Participants will take one dose of Propranolol (40mg IR) on two separate occasions.

Placebo

Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will take one dose of Placebo on two separate occasions.

Interventions

Propranolol

Participants will take one dose of Propranolol (40mg IR) on two separate occasions.

Intervention Type: DRUG

Placebo

Participants will take one dose of Placebo on two separate occasions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason A Oliver, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University School of Medicine

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00083809

Identifier Type: -

Identifier Source: org_study_id