Combined Pharmacotherapies for Alcoholism (Naltrexone/Ond... | NCT00027079

Studies
Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

NCT00027079

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Status

Completed

Last Update Posted

Dec 10, 2007Estimated

Enrollment

360

Phase

Phase 2

Conditions

Alcoholism

Interventions

ondansetron (Zofran)
naltrexone (ReVia)
Cognitive Behavioral Therapy

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

Dec 2007

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

Sep 2001

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

Nov 20, 2001

First Submission Date that Met QC Criteria

Nov 20, 2001

First Posted Date

Nov 21, 2001Estimated

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

Dec 7, 2007

Last Update Posted Date

Dec 10, 2007Estimated

Description Module

Brief Summary

This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Current diagnosis of alcohol dependence.
Provide a written informed consent.
Must weigh within 30% of their ideal body weight.
Patients must weigh at least 89 lbs. and no more than 342 lbs.
Good physical health.
Currently drinking 14 or more alcohol units per week for women and 21 or more alcohol units per week for men in the last 30 days.
Provide evidence of stable residence in the last month prior to enrollment in the study.
No plans to move in the nine months after entering the study.
Literate in English and able to read, understand, and complete questionnaires and follow instructions.
Willingness to participate in behavioral treatment for alcoholism.

Exclusion Criteria:

Current psychiatric disorder other than alcohol or nicotine dependence.
Elevated liver enzymes or elevated bilirubin.
Severe alcohol withdrawal symptoms which require treatment.
Serious medical co-morbidity requiring medical intervention or close supervision.
Severe or life-threatening adverse reactions to medications in the past or during this trial.
Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
Received inpatient or outpatient treatment for alcohol dependence within the last 30 days.
Compelled to participate in an alcohol treatment program for alcohol dependence to maintain their liberty.
Members of the same household.
Tuberculosis.
Current treatment with any medications having a potential effect on alcohol consumption and related behaviors or mood.
Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
Pyrexia of unknown origin.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
ondansetron (Zofran)	Drug
naltrexone (ReVia)	Drug
Cognitive Behavioral Therapy	Behavioral

ID	Term
D017294	Ondansetron
D009271	Naltrexone
D015928	Cognitive Behavioral Therapy