RECRUITING

Sex Differences in the Response to Abstinence From Alcohol.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. In the present study, the investigators propose to study how men and women respond to abstinence, and whether this information can be used to improve intervention and prevention strategies.

Official Title

Sex Differences in the Response to Abstinence From Alcohol.

Quick Facts

Study Start:2019-04-10
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03827460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Moderate social drinkers
  2. * Able to understand/complete questionnaires and procedures in English
  3. * Body mass index (BMI) between 18.5 and 32 kg/m2
  4. * Have venous access sufficient to allow blood sampling
  1. * Pregnant or breast-feeding women, or women who intend to become pregnant
  2. * Do not attest to using accepted forms of birth control for the infusion phase of the study
  3. * Current treatment for, or desire to be treated for, any substance use disorder or court ordered to not drink alcohol
  4. * History of significant adverse reaction to alcohol
  5. * Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety
  6. * Medications (past 30 days) that could influence data or participant safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by investigators
  7. * DSM 5 Disorders (non AUD) or current/history of neurological disease of cerebral origin, or head injury with \> 20 min loss of consciousness
  8. * Positive breath alcohol reading on arrival at any study visit
  9. * 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
  10. * Any condition for which the principal investigators determine it is unsafe or not prudent to enroll

Contacts and Locations

Study Contact

Ann E Kosobud, Ph.D.
CONTACT
(317) 274-0087
akosobud@iupui.edu

Principal Investigator

Martin H Plawecki, MD, PhD
PRINCIPAL_INVESTIGATOR
Psychiatry, Indiana University School of Medicine
Melissa A Cyders, PhD
PRINCIPAL_INVESTIGATOR
Psychology, Indiana University-Purdue University at Indianapolis

Study Locations (Sites)

University Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Martin H Plawecki, MD, PhD, PRINCIPAL_INVESTIGATOR, Psychiatry, Indiana University School of Medicine
  • Melissa A Cyders, PhD, PRINCIPAL_INVESTIGATOR, Psychology, Indiana University-Purdue University at Indianapolis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-10
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2019-04-10
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Alcohol
  • Alcoholism
  • Sex Differences
  • Abstinence
  • Alcohol Deprivation Effect

Additional Relevant MeSH Terms

  • Alcohol Use Disorder