A Timeline Study of Alcohol Use and Its Relationship to Insomnia

NCT00580411 | Completed

• 3 other identifiers: HR#16934Contract ID ESRC343DPMCDA
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia; Alcohol Problem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Alcohol Problem First

Alcohol Problem precedes Insomnia

Insomnia First

Insomnia Precedes Alcohol Problem

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Robert Malcolm, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 24, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 11, 2017

Record last verified: 2015-10

Locations

US (1)