Phase 4
Completed N=44
Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity
Cigarette Smoking
Source: ClinicalTrials.gov NCT03309943 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: BOLD Activation to Smoking Cues - Amygdala — 0.002471; 0.077325; 0.009450; 0.090345 Percent Signal Change — p=.019
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BOLD Activation to Smoking Cues - Amygdala |
0.002471; 0.077325; 0.009450; 0.090345; 0.044903; 0.042836 | .019 sig |
| PRIMARY BOLD Activation to Smoking Cues - Anterior Insula |
-0.179076; -0.157851; -0.127730; -0.142636; -0.118271; -0.152299 | .830 |
| PRIMARY BOLD Activation to Smoking Cues - Anterior Hippocampus |
0.061001; 0.095120; 0.073925; 0.088399; 0.133369; 0.083638 | .006 sig |
| PRIMARY BOLD Activation to Smoking Cues - Posterior Hippocampus |
0.161077; 0.185521; 0.156684; 0.166154; 0.137124; 0.161655 | .653 |
| PRIMARY BOLD Activation to Smoking Cues - Medial Prefrontal Cortex |
0.033030; 0.012705; 0.058184; 0.060320; -0.078483; -0.167025 | .012 sig |
| PRIMARY fMRI BOLD Connectivity |
-0.0740; 0.0228 | .013 sig |
| PRIMARY Cue-Provoked Craving - Proximal Cues |
2.866883; 1.898148; 6.103084; 6.547619 | .024 sig |
| PRIMARY Cue-Provoked Craving - Standard Environment Images |
2.673052; 1.763889; 4.666937; 4.868056 | .086 |
| PRIMARY Cue-Provoked Craving - Personal Environment Cues |
3.369318; 2.965278; 6.045996; 6.638889 | .140 |
| SECONDARY Laboratory Visit - Self-Reported Craving |
7.3; 7.9 | .556 |
| SECONDARY Laboratory Visit - # Cigarette Puffs |
15.2; 17.7 | .463 |
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.
Data sourced from ClinicalTrials.gov (NCT03309943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.