Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking

NCT00183222 | Completed Phase 2

• 3 other identifiers: NIAAAANT010761-2005aP50AA010761NIH Grant P50 AA010761
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist medication approved to treat nausea) or their combination are effective in the reduction of alcohol craving and drinking compared to placebo.

Conditions

Alcohol Dependence

Keywords

Alcohol dependence; Alcoholism; Craving

Outcome Measures

Primary Outcomes (4)

• "Natural" alcohol consumption period -- Total number of drinks consumed during the 5 day observation period

• Pharmacological effects of alcohol consumption -- Average BAES stimulation score

• Limited access alcohol consumption paradigm -- Total number of drinks consumed

• Cue induced brain imaging -- Alcohol beverage cue minus neutral beverage cue activity in nucleus accumbens and insula

Secondary Outcomes (5)

• Change in craving as measured by the OCDS from pre-study to end of 5 day period

• Change in craving from pre to post-alcohol ingestion

• Change in craving during limited-access alcohol consumption

• Change in craving during cue-induced brain activity

• Side effects of medications

Interventions

naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days DRUG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 65
• Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 4) but does not necessarily have signs of physiologic dependence as expressed in criterion for tolerance development (criterion 1) and withdrawal symptoms or use to avoid withdrawal symptoms (criterion 2).
• Currently is not engaged in, and does not want treatment for, alcohol related problems.
• Able to read and understand questionnaires and informed consent.
• Lives within 50 miles of the study site.
• Able to maintain abstinence for up to three days (without the aid of detox medications) as determined by self report and breathalyzer measurements.
• Age 21 65
• Does not meet the DSM IV criterion for lifetime or current alcohol abuse or dependence.
• Consumes, on average, less than 14 standard drinks per week. But has consumed at least 2 standard drinks on at least one occasion in the last month.
• Currently is not engaged in, and does not want, treatment for alcohol related problems.
• Able to read and understand questionnaires and informed consent.
• Able to maintain abstinence for three days.
• Does not have metal objects in the head/neck.
• Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
• Between the age of 25-45 years.

You may not qualify if:

• Currently meets DSM IV criteria for any other psychoactive substance dependence disorder.
• History of opiate abuse or a positive urine drug screen for opiates.
• Any psychoactive substance use (except marijuana and nicotine) within the last 30 days as evidenced by self-report and urine drug screen. For marijuana -no use within the last seven days.
• Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders and eating disorders, any other psychotic disorder or organic mental disorder.
• Has current suicidal ideation or homicidal ideation.
• Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications.
• Current use of disulfiram.
• Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion.
• Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
• Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening.
• Females of child bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
• Has current charges pending for a violent crime (not including DUI related offenses).
• Does not have a stable living situation.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Drug and Alcohol Programs, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone; Ondansetron; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Raymond F Anton, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 5, 2010

Record last verified: 2010-05

Locations

US (1)