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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014