Alcohol Problem, Insomnia
Conditions
Brief summary
This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.
Interventions
None listed
Sponsors
Sumitomo Pharma America, Inc.
National Institute on Drug Abuse (NIDA)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the temporal relationship between insomnia and alcohol dependence, alcohol abuse or heavy drinking and determine if this relationship affects the severity of alcohol use. | Visit 1 |
Secondary
| Measure | Time frame |
|---|---|
| To assess the utility of 3 sleep disorder instruments: the ISI, the SDQ-8 & the ESS in an inpatient or outpatient population of subjects reporting insomnia with a lifetime history of alcohol dependence, alcohol abuse or heavy drinking. | Visit 1 |
Countries
United States
Outcome results
None listed