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A Timeline Study of Alcohol Use and Its Relationship to Insomnia

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ClinicalTrials.gov Identifier: NCT00580411
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
, National Institute on Drug Abuse (NIDA)

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

Condition or disease
Insomnia Alcohol Problem

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Timeline Study of Alcohol Use and Its Relationship to Insomnia
Study Start Date : March 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Group/Cohort
Alcohol Problem First
Alcohol Problem precedes Insomnia
Insomnia First
Insomnia Precedes Alcohol Problem



Primary Outcome Measures :
  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. [ Time Frame: Visit 1 ]

Secondary Outcome Measures :
  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. [ Time Frame: Visit 1 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580411


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Sunovion
Investigators
Principal Investigator: Robert Malcolm, MD Medical University of South Carolina

Responsible Party: , Principal Investigator, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00580411     History of Changes
Other Study ID Numbers: HR#16934
Contract ID ESRC343
DPMCDA
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2015

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs