Clinical trial NCT00580411: A Timeline Study of Alcohol Use and Its Relationship to Insomnia
Official title: A Timeline Study of Alcohol Use and Its Relationship to Insomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Alcohol Problem
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2007-12-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We wish to study individuals who meet lifetime criteria for alcohol dependence, abuse or heavy drinking and who self-report current insomnia.

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


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Visit 1
Secondary outcomes:
measure: 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.
timeFrame: Visit 1
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Robert Malcolm, MD
role: PRINCIPAL_INVESTIGATOR
References: