Examining how men and women respond differently to abstaining from alcohol.
Sex Differences in the Response to Abstinence From Alcohol.
This study looks at how men and women react differently to stopping alcohol for a while to help understand their drinking habits better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 21 Years to 35 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT03827460 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in alcohol consumption responses between men and women following periods of abstinence from alcohol. It builds on previous findings that suggest abstinence affects drinking behavior differently based on sex. The research involves controlled alcohol exposure and a two-year follow-up to assess natural drinking patterns and the impact of self-reported abstinence on drinking trajectories. The ultimate goal is to enhance understanding of sex differences in alcohol use disorders and to inform the development of tailored intervention strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are moderate social drinkers who meet specific health criteria and can engage in the study's procedures.
Not a fit: Patients with a history of significant adverse reactions to alcohol or those currently undergoing treatment for substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, sex-specific interventions for individuals struggling with alcohol use disorders.
How similar studies have performed: Other studies have indicated that understanding sex differences in alcohol consumption can lead to improved treatment strategies, suggesting this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Moderate social drinkers * Able to understand/complete questionnaires and procedures in English * Body mass index (BMI) between 18.5 and 32 kg/m2 * Have venous access sufficient to allow blood sampling Exclusion Criteria: * Pregnant or breast-feeding women, or women who intend to become pregnant * Do not attest to using accepted forms of birth control for the infusion phase of the study * Current treatment for, or desire to be treated for, any substance use disorder or court ordered to not drink alcohol * History of significant adverse reaction to alcohol * Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety * Medications (past 30 days) that could influence data or participant safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by investigators * DSM 5 Disorders (non AUD) or current/history of neurological disease of cerebral origin, or head injury with \> 20 min loss of consciousness * Positive breath alcohol reading on arrival at any study visit * Actively suicidal (for example, any suicide attempts within the past year or any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the investigator * Any condition for which the principal investigators determine it is unsafe or not prudent to enroll
Where this trial is running
Indianapolis, Indiana
- University Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Martin H Plawecki, MD, PhD — Psychiatry, Indiana University School of Medicine
- Study coordinator: Ann E Kosobud, Ph.D.
- Email: akosobud@iupui.edu
- Phone: (317) 274-0087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.