Status:
COMPLETED
Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
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 tr...
Detailed Description
Non-treatment seeking individuals meeting criteria for alcohol dependence N=160) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will b...
Eligibility Criteria
Inclusion
- Inclusion Criteria (alcohol dependent group):
- 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.
- Inclusion Criteria (social drinker group):
- 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.
- Inclusion for fMRI imaging sub-study (see methodology section for rationale):
- 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.
- Does not currently smoke (note: 62% of our current sample are non-smokers).
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00183222
Start Date
May 1 2005
End Date
December 1 2005
Last Update
May 5 2010
Active Locations (1)
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1
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425