Familial Risk for Bipolar Disorder and Alcohol Sensitivity — FACS  

Bipolar Disorder Clinical Trial

Official title: Dissecting Responses to Alcohol in Individuals With Familial Risk for Bipolar Disorder

Status Recruiting

Clinical Trial Summary

Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is to use alcohol administration procedures and alcohol biosensor technology to investigate responses to alcohol, compared to placebo, and relationship with parental risk for alcohol use disorders and/or bipolar disorder in young adults. Baseline clinical, cognitive, and behavioral assessments will be completed in 100 young adults (21-26 years; 50% women, no history of AUDs>mild). Participants would be equally divided among those with parental history of bipolar disorder but not AUDs, parental history of bipolar disorder and AUDs, parental history of AUDs but not bipolar disorder, and typically developing age- and sex-matched controls with no parental history of mood disorders or AUDs (N=25 per group). Then, while wearing Secure Continuous Remote Alcohol Monitoring [SCRAM] sensors, participants will complete within-person, counter-balanced, beverage sessions (following standard beverage administration procedures) in a simulated bar laboratory. Changes in heart rate, body sway and subjective self-report measurements of intoxication will also be completed while under the influence of alcohol or placebo. Specifically, individual differences in transdermal alcohol concentration (the primary data output from SCRAM sensors), physiological changes (e.g. heart rate), and the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) will be investigated and differences between parental risk subgroups and healthy comparison participants investigated. Differences in transdermal alcohol concentration collected while under the influence of alcohol will be the primary data outcome assessed. Changes in heart rate, body sway, and experience of stimulating, sedative, and anxiolytic effects (from self-report survey data) while under the influence of alcohol compared to placebo session will also be investigated. Additionally, associations between objective and subjective responses to alcohol and drinking patterns will be explored (secondary outcome). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions.

Clinical Trial Description

A total of 100 young adults (21-26 years; 50% women, no history of AUDs>mild) will be recruited from the greater Austin area. Participants will be equally divided among those with parental history of bipolar disorder but not AUDs, parental history of bipolar disorder and AUDs, parental history of AUDs but not bipolar disorder, and typically developing age- and sex-matched controls with no parental history of mood disorders or AUDs (N=25 per group). The phone screen used for this study will assess parental history and clinical symptoms to achieve these recruitment goals for each subgroup.

Once recruited and enrolled, subjects will undergo detailed structured clinical evaluations to verify inclusion and exclusion criteria (including family history), comprehensive assessment of alcohol and other drug use history, and cognitive testing. Participants will return to the laboratory on subsequent days and complete their alcohol/placebo sessions while wearing Secure Continuous Remote Alcohol Monitoring (SCRAM) sensors and under the influence of alcohol or a placebo condition (counter-balanced). Following standard beverage administration procedures in a simulated bar laboratory, changes in heart rate, body sway, and self-report measures of subjective response to alcohol will be measured. Up to four participants will complete the beverage session together in the bar laboratory. This increases the ecological validity and strengthens the placebo manipulation. It also increases subject flow. Participants will be escorted to a private assessment room for all behavioral assessments. For each participant the first beverage session assignment (whether the participant is given alcohol or the placebo beverage first) will be randomized. The SCRAM sensor will be worn continuously and measure transdermal alcohol concentration throughout the alcohol and placebo sessions. Participants will wear the SCRAM sensor home overnight following their alcohol session and return the next morning for SCRAM sensor removal. Transdermal alcohol concentration is continuously collected overnight following an alcohol session. Participants will not be required to wear the SCRAM sensor home after their placebo session. For the placebo session, we will inform participants they received a low dose of alcohol and that their BrAC is at 0.0g% at the end of the session so monitoring overnight is not needed. Alcohol and placebo sessions will occur within 3 days of each other.

For both the alcohol and the placebo beverage conditions, the protocol will be the same. The beverage administration sessions will in a simulated bar laboratory in co-Investigator, Kim Fromme's, research suite at the University of Texas at Austin. The table in the testing room will be wiped down with alcohol prior to the participant's arrival (olfactory cue). Study staff will use an algorithm to calculate individual alcohol doses based on the participants' age, sex, height, and weight. Participants fast from food for 4 hours prior to their session. Before beginning consumption of their beverages, they will eat a weight-adjusted, 1 calorie per pound snack of pretzels. While participants eat their pretzels, study staff will mix beverages in front of participants. Vodka and placebo (decarbonated tonic water) will be stored in absolute vodka bottles, measured out, and combined with mixer in front of participants. Mixed drinks will be poured into glasses that have been sitting face down with rims soaking in vodka. Prior to giving the beverage to the participant, all drinks will get an alcohol floater (squirt of absolute vodka on top of the drink). Participants will be given 20 minutes to orally consume two beverages (10 minutes per beverage).

Following oral consumption and a 15-minute absorption period, breathalyzer tests will be conducted every 10 minutes to identify a .06g% ascending limb breath alcohol concentration (BrAC). Heart rate, body sway, and self-report of response to alcohol will be collected. BrAC will be measured at approximate 10 minute intervals, and heart rate, body sway, and subjective response to alcohol collected again at peak BrAC (0.08g%) and at descending BrAC of .06g%. Baseline heart rate, body sway, and self-report response (with instructions modified to ask how participants feel when they first arrive to the laboratory) are also collected before sessions begin so change on test days (e.g. peak 0.08g% BrAC heart rate - baseline heart rate) is calculated. Consistent with NIAAA guidelines for human alcohol studies, BrAC readings will continue every 30 minutes until participants are below 0.04% at which time they are escorted home. During the placebo condition, participants are told they will receive varying doses of alcohol, provided ambient olfactory cues, the rims of glasses are soaked in vodka, and alcohol floater is added to beverages (gustatory cues). A placebo manipulation test is measured during the ascending limb (placebo: after the absorption period with time of test given at the average time it takes individuals to reach ascending 0.06g% BrAC during the alcohol session) and when participants reach ascending 0.06g% BrAC (during alcohol session). Participants are asked to estimate the number of standard alcoholic drinks they were served. The average time participants stay in the laboratory will be shorter for the placebo vs. alcohol beverage condition. Participants are told they received a lower dose of alcohol and at the end of the placebo session they are told their BrAC is 0.0g%. They therefore do not need to wear the SCRAM sensor home. During the alcohol session participants are released at 0.04g% and they are told they need to wear the SCRAM sensor home overnight. Participants are debriefed, including BrAC reached during sessions, after they complete both sessions. ;

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Bipolar Disorder

• NCT number: NCT04716036
• Study type: Interventional
• Source: University of Texas at Austin
• Contact: Research Coordinator
• Phone: (512) 495-5198
• Email: behavioral.neuroimaging@austin.utexas.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2021
• Completion date: July 31, 2024