A Timeline Study of Alcohol Use and Its Relationship to Insomnia

Insomnia Clinical Trial

Official title:

A Timeline Study of Alcohol Use and Its Relationship to Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580411
• Other study ID #: HR#16934
• Secondary ID: Contract ID ESRC
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2007
• Last updated: January 10, 2017
• Start date: March 2007
• Est. completion date: May 2009

Study information

• Verified date: October 2015
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alcohol Problem
• Insomnia
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No