Clinical trial NCT05155176: Novel Real-world Methods in Social Drinkers and AUD
Official title: Novel Methods for Investigating Stress-related Processes in Social Drinkers and Individuals With Alcohol Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Drinking
Alcohol Abuse
Alcohol Use Disorder
Keywords: Alcohol Use Disorder
Smartphone
Alcohol
Cortisol
Heart rate variability
Ecological Momentary Assessment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Peter McManus Charitable Trust
First posted: 2021-12-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Meets current or past DSM-5 criteria for Axis I for major psychiatric disorders, other than depression or anxiety disorder;
2. Meets criteria for a current Substance Use Disorder other than Alcohol or mild Cannabis Use Disorder;
3. Has any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions;
4. Reports current use of medications/drugs that interfere with HPA axis response,
5. Are women who are pregnant or lactating;
6. Report current use of psychotropic drugs other than antidepressants.

Brief summary: This research project proposes a novel approach to elucidate the biological adaptations associated with Alcohol Use Disorder and to assess whether such adaptations are predictive of higher alcohol craving in response to both alcohol cues and stressors and higher relapse risk and alcohol use in the real world.

Detailed description: We will use intensive longitudinal data collection and analysis across multiple data streams. We will recruit 25 treatment-seeking individuals with AUD and 25 light social drinkers matched on demographically relevant variables (i.e., age, gender, IQ, race). We will use smartphones to assess subjects' alcohol use and experiences in real-time via ecological momentary assessment (EMA). During three consecutive days of these two weeks, we propose using passive biomonitoring to collect real-time cardiovascular responses, i.e., heart rate variability (HRV), and alcohol use via unobtrusive monitors (i.e., Firstbeat Bodyguard 2, BACtrack Skyn) with scheduled salivary cortisol samples. Individuals with AUD will then be provided with four weeks of behavioral treatment with daily assessments. During the final two weeks of treatment, individuals with AUD will complete another three-day period of intensive self-reports, including another 72-hours physiological and salivary cortisol monitoring.

Eligibility criteria: Inclusion Criteria:

Men and women who:

1) Are older than 18 years old at the first intake appointment; 2) Are fluent in English; 3) Are drinking alcohol at levels to match either of the two groups:

a. Social drinkers: i. Must report a past-year history of alcohol use ii. Must not meet current AUD and may have only met mild AUD during their lifetime (not within the past year) iii. Provide a negative urine toxicology screen. b. Individuals with Alcohol Use Disorder: i. Must meet current criteria for AUD based on the SCID (≤ 2 symptoms in past year); ii. Report at least weekly use of alcohol. iii. Do not meet criteria for any other substance use disorders other than mild Cannabis Use Disorder.

iv. Provide a positive urine toxicology screen for alcohol during intake. 5) Can provide written informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Rating of subjective craving in the real world
timeFrame: 42 days for individuals with AUD, 14 days for social drinkers
measure: Rating of subjective stress in the real world
timeFrame: 42 days for individuals with AUD, 14 days for social drinkers
measure: Heart rate response to stress and cannabis cues in the real world
timeFrame: 6 days for individuals with AUD, 3 days for social drinkers
measure: Cortisol response to stress and cannabis cues in the real world
timeFrame: 6 days for individuals with AUD, 3 days for social drinkers
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephanie Wemm, PhD
role: PRINCIPAL_INVESTIGATOR
References: