Table 1.
Comparison of Ingestion and Infusion Paradigms
| Aspect of Method | Ingestion | Intravenous Infusion |
|---|---|---|
| Control: controlled variable for alcohol administration | Dose of alcohol ingested | BrAC Trajectory |
| Control: main barrier to precision | Uncontrollable absorption | BrAC meter precision |
| Control: individual peak BrAC | SD ~ 20-30% of intended mean | SD ~ 3% of intended mean |
| Control: latency to peak BrAC | SD ~ 25 min | SD ~ 2 min |
| Control of overall BrAC trajectory | Poor: see Figure 1A-1C | Precise: see Figure 1D |
| Control: first pass metabolism | Uncertain and uncontrollable | None |
| Power: Influence on size of sample population required for adequate hypothesis testing | Determined by concern for dealing with within-group variability in brain exposure to alcohol during analysis | Maximized by elimination of absorption and individualized modeling of alcohol distribution and elimination kinetics |
| Safety: reservoir effect | Unavoidable | Does not exist |
| Safety: peak BrAC | Mean value limited by uncertainty: absorption kinetics vs. toxicity | Limited by toxicity only: investigator specifies a preset value that cannot be exceeded by participants. |
| Ability to control beverage characteristics, including concentration, amount, taste, aroma, texture, and temperature | Excellent, but need to control them all, and to know relationship of each to subject’s preference | No beverage, but important to know infusate alcohol concentration, and to control infusate temperature |
| Ability to blind the first data-collection technician regarding alcohol vs. control beverage | Good | Currently unavailable |
| Ability to control for expectancy effects with an effective placebo control | Good to excellent depending on aspects of study design | Good to excellent depending on aspects of study design |
| Use of preferred alcoholic beverages | Feasible but uncommon | Not applicable |
| Presence of sensory cues associated with alcohol consumption | Excellent; olfactory and taste cues and behavioral responses (e.g., drinking from a glass). | Limited on purpose, but can be added depending on experimental question |
| Documentation of BrAC achieved | Stored, BrAC meter readings; unchecked if technician blinded | Real-time, monitored BrAC meter readings and continuous estimate of BrAC |
| Documentation of events, comments | Manual, changeable record | Time-stamped, permanent record |
| Documentation of dosing schedule in each session | Intermittent, by technician | Continuous, by CAIS |
| Laboratory settings where research can be conducted | Includes simulated bar, lab, simulated living room, fMRI, CT, etc. | Includes simulated bar, lab, CT, SPECT, PET, and fMRI |
| Inclusion of social interaction as variable of interest | Possible, limited, published | currently limited, unpublished |
| Repeated within-session administrations | Easy, but unreliable result | Easy and reliable |
| Ability to study acute within-session tolerance | Possible but typically confounded by limb effects | Easy and reliable |
| Main domain of validity | Ecological route of administration | Ecological alcohol exposures |
| Cost; # technicians required for per-session data collection | Minimum of 1; 2 if blinding required | Minimum of 1; 2 if blinding required |
| Cost: preparation of beverage/alcohol administered | Variable; usually by lab technician from readily available components | Infusate: $150 – $300 per session; usually performed by a research pharmacy |
| Cost: optimization of alcohol delivery paradigm | Variable depending on investigator experience | 20 hours including free consultation using CAIS simulation mode |
| Cost: training of technicians | Weeks on protocol | Weeks on protocol + Days on CAIS |
| Cost: CAIS hardware | $0 | $2,500 - $4,000 |
| Cost: CAIS software | $0 | $0 if paradigm used anywhere previously |
| Cost: CAIS bench testing | $0 | Free, but shipping at cost |
| Cost: CAIS training | $0 | ~ $500 a day + travel |
Note. BrAC= Breath Alcohol Concentration; CAIS= Computer Assisted Infusion Software