Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04716036
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2021-01-12
Brief Title:
Familial Risk for Bipolar Disorder and Alcohol Sensitivity
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Dissecting Responses to Alcohol in Individuals With Familial Risk for Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FACS
Brief 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 andor 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 AUDsmild 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 N25 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 eg 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
Detailed Description:
A total of 100 young adults 21-26 years 50 women no history of AUDsmild 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 N25 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 alcoholplacebo 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 00g 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 Frommes research suite at the University of Texas at Austin The table in the testing room will be wiped down with alcohol prior to the participants 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 008g 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 eg peak 008g 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 004 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 006g BrAC during the alcohol session and when participants reach ascending 006g 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 00g They therefore do not need to wear the SCRAM sensor home During the alcohol session participants are released at 004g 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
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 alcoholplacebo 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 00g 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 Frommes research suite at the University of Texas at Austin The table in the testing room will be wiped down with alcohol prior to the participants 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 008g 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 eg peak 008g 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 004 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 006g BrAC during the alcohol session and when participants reach ascending 006g 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 00g They therefore do not need to wear the SCRAM sensor home During the alcohol session participants are released at 004g 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None