Sex Differences in the Response to Abstinence From Alcohol.

1809467722

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.

2019-04-10

2026-03-31

2026-03-31

Recruiting

Early phase I

160

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arms 1 and 2: 2 session parallel, random order, no blind.\n\nArm 3: Sequential, includes all subjects who complete Arm1 or Arm 2', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The intervention is 2 weeks of monitored abstinence from alcohol compared to usual drinking. Thus, it is not possible to mask conditions for participants or investigators.'}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

2024-04-25