A Timeline Study of Alcohol Use and Its Relationship to Insomnia

National Institutes of Health (NIH)

Status: Completed

Conditions: Insomnia; Alcohol Problem

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT00580411

HR#16934

Contract ID ESRC343

DPMCDA

Details and patient eligibility

About

This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects must be between the ages of 18-70, may be male or female, and from any ethnic background.
• Individuals must have the capacity to give IRB-approved study consent.
• Subjects must at least have a lifetime history of being heavy alcohol drinkers (i.e., drinks approximately 21 alcoholic drinks or more per week). Alternatively, subjects are eligible if they meet criteria for a lifetime history of either alcohol dependence or alcohol abuse. Overall, a subject must meet at least one of these alcohol criteria: a lifetime history of heavy drinking, alcohol abuse or alcohol dependence.
• Subjects must have a complaint of chronic insomnia, reporting either six or less hours TST, on average at least three times per week.

Exclusion Criteria

• Potential subjects with a lifetime diagnosis of Bipolar Affective Disorder, Schizophrenia, Borderline Personality Disorder, dementia of any type, or epilepsy will not be admitted to the study.
• Subjects will be excluded with a diagnosis of any other substance dependence syndrome other than alcohol dependence, nicotine dependence, and/or caffeine dependence. However, individuals may have a history of episodic abuse of cannabis, cocaine, sedatives/hypnotics and opiates, amphetamines, and hallucinogens. Also, subjects may be on prescription benzodiazepine or related sedative/hypnotic therapy.
• Any condition or treatment of a condition that is likely to confound the experimental design or the results will be prohibited by the PI.

Trial design

75 participants in 2 patient groups

Alcohol Problem First

Description:

Alcohol Problem precedes Insomnia

Insomnia First

Description:

Insomnia Precedes Alcohol Problem