A Timeline Study of Alcohol Use and Its Relationship to Insomnia

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Robert Malcolm, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00580411
First received: December 19, 2007
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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


Condition Phase
Insomnia
Alcohol Problem
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Timeline Study of Alcohol Use and Its Relationship to Insomnia

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alcohol Problem First
Alcohol Problem precedes Insomnia
Insomnia First
Insomnia Precedes Alcohol Problem

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580411

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Sunovion
Investigators
Principal Investigator: Robert Malcolm, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Robert Malcolm, 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
Study First Received: December 19, 2007
Last Updated: October 16, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Sleep Initiation and Maintenance Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014