A Timeline Study of Alcohol Use and Its Relationship to I... | NCT00580411

Studies
A Timeline Study of Alcohol Use and Its Relationship to Insomnia

NCT00580411

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 11, 2017Estimated

Enrollment

75Actual

Phase

Not provided

Conditions

Insomnia
Alcohol Problem

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 19, 2007

First Posted Date

Dec 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2017

Last Update Posted Date

Jan 11, 2017Estimated

Name	Class
Sumitomo Pharma America, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Label	Type	Description	Intervention Names
Alcohol Problem First		Alcohol Problem precedes Insomnia
Insomnia First		Insomnia Precedes Alcohol Problem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

We wish to study individuals who meet lifetime criteria for alcohol dependence, abuse or heavy drinking and who self-report current insomnia.

Sampling Method

Non-Probability Sample

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D019973	Alcohol-Related Disorders

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Type	Description	Link
Contract ID ESRC343
DPMCDA