N/A
N=131
Neurobiological Responses in Alcoholism and Early Trauma
Alcohol Use Disorder · Early Trauma Complications
Bottom Line
View on ClinicalTrials.gov: NCT04128228 ↗Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Brain Response — .015; .010; -.013; .08 unitless — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 8-week outpatient treatment (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Response |
.015; .010; -.013; .08; .071; .058 | <0.05 sig |
| PRIMARY Stress Hormone Response (Cortisol to ACTH Ratio) |
.14; .11; .19; .17 | <0.01 sig |
| PRIMARY Time to Relapse |
22.8; 5.6 | <0.05 sig |
| SECONDARY Amount of Alcohol Consumption (Weekly) |
5.6; 13.1 | <0.01 sig |
| SECONDARY Frequency of Alcohol Use (Percentage) |
26.1; 45.4 | <0.05 sig |
Summary
Alcohol use disorder (AUD) accompanied by early trauma presents clinical challenges, including elevated rates of comorbid emotional symptoms and relapse. To better understand this co-occurring condition, this study investigates the neurobiological responses associated with AUD and early trauma. Using a multimodal neuroimaging approach, including functional magnetic resonance imaging (fMRI), the study concurrently measures brain activity and stress hormone responses in individuals with AUD and control participants, both with and without early trauma. The primary goal is to examine neurobiological responses and relapse patterns following treatment in individuals with AUD, with and without a history of early trauma. Conventional alcohol treatments often fail to specifically address the emotional complications in AUD individuals with early trauma. Therefore, this study also explores whether incorporating stress regulation into alcohol relapse prevention can improve outcomes for this population. Following baseline assessments that included multimodal neuroimaging, all participants with AUD received an 8-week outpatient treatment program integrating cognitive-behavioral methods focused on emotion regulation with stress reduction techniques, particularly self-regulated breathing strategies.
Eligibility Criteria
AUD inclusion Criteria:
- Alcohol use disorder
- Either low or high early trauma (based on the Childhood Trauma Questionnaire)
- Body mass index (BMI) up to 35 (due to weight limitations of the MRI scanner)
AUD exclusion Criteria:
- Current or past substance use disorder other than alcohol; excluding caffeine and nicotine
- Psychiatric disorders except for mood and anxiety disorders
- Any significant current medical conditions
- Women who are peri- and post- menopausal, pregnant or lactating
- MRI specific exclusion criteria (e.g., claustrophobia, implanted metal in the body)
Data sourced from ClinicalTrials.gov (NCT04128228). 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.