N/A N=49 Other

Alcohol Monitor Validation

Human Immunodeficiency Virus (HIV)

Bottom Line

View on ClinicalTrials.gov: NCT03617705 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Transdermal Alcohol Concentration (TAC) — 38.3; 95.8 ug/L

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Skyn Monitor Lab Session 1 (Device); Skyn Monitor Field Test with EMA App (Device); Skyn Monitor Lab Session 2 (Device)
Age: Adult · 21+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Transdermal Alcohol Concentration (TAC)	38.3; 95.8	—

Summary

This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and real-life settings.

Eligibility Criteria

Inclusion Criteria

HIV+ consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks
HIV- consumers of alcohol; self-reported ≥ 5 days with at least 1 alcoholic drink, and ≥1days with at least 3 drinks

Exclusion Criteria

non-drinkers
recent addiction treatment or treatment seeking
urine positive for illegal drugs except THC (not applicable to those who are only invited to do field test);
past & current alcohol withdrawal
severe alcohol use disorder (DSM-5)
meeting criteria for current nicotine dependence (not applicable to field only participants) or current substance use disorder (excluding mild cannabis use disorder and mild/moderate alcohol use disorder)
medical conditions (other than HIV) contraindicating alcohol
pregnancy/breastfeeding in women
psychosis or other severe psychiatric conditions.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03617705). 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.