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
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Purpose
This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.
| 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 May 16, 2013