Expired Study
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Charleston, South Carolina 29425


Purpose:

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.


Study summary:

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 be assigned through urn randomization (using a double dummy placebo controlled design) to one of four experimental groups, naltrexone (50 mg/day) (N=40), ondansetron (0.25 mg twice a day) (N=40), naltrexone and ondansetron (N=40) or placebos (N=40). Subjects will take the study drugs for 8 days (day 1-5 being the natural observation period). After a minimum of 48 hours of abstinence from alcohol day 6-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.A subset of subjects from each medication group (N=15) will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. A smaller group of social drinker controls (N=16), recruited and paid in a similar fashion, will be randomly assigned to the same medication groups (4 per group). They will be used as procedure controls for the alcohol administration lab study and as a comparison/contrast group for the brain imaging sub-study.


Criteria:

Inclusion Criteria: Inclusion Criteria (alcohol dependent group): 1. Age 21 65 2. 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). 3. Currently is not engaged in, and does not want treatment for, alcohol related problems. 4. Able to read and understand questionnaires and informed consent. 5. Lives within 50 miles of the study site. 6. 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): 1. Age 21 65 2. Does not meet the DSM IV criterion for lifetime or current alcohol abuse or dependence. 3. 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. 4. Currently is not engaged in, and does not want, treatment for alcohol related problems. 5. Able to read and understand questionnaires and informed consent. 6. Able to maintain abstinence for three days. Inclusion for fMRI imaging sub-study (see methodology section for rationale): 1. Does not have metal objects in the head/neck. 2. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms. 3. Between the age of 25-45 years. 4. Does not currently smoke (note: 62% of our current sample are non-smokers). Exclusion Criteria: 1. Currently meets DSM IV criteria for any other psychoactive substance dependence disorder. 2. History of opiate abuse or a positive urine drug screen for opiates. 3. 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. 4. 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. 5. Has current suicidal ideation or homicidal ideation. 6. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications. 7. Current use of disulfiram. 8. Clinically significant medical problems such as, cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion. 9. Past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis. 10. Hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2 1/2 times normal at screening. 11. Females of child bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control. 12. Has current charges pending for a violent crime (not including DUI related offenses). 13. Does not have a stable living situation.


Study is Available At:


Original ID:

NIAAAANT010761-2005a


NCT ID:

NCT00183222


Secondary ID:

P50AA010761


Study Acronym:


Brief Title:

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


Official Title:

Alcohol Research Center Grant. Component #1. COMBINING MEDICATIONS: ALCOHOL REACTIVITY AND CONSUMPTION


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

160


Enrollment Type:


Overall Contact Information

Official Name:Raymond F Anton, MD
Principal Investigator
Medical University of South Carolina

Study Dates

Start Date:May 2005
Completion Date:December 2005
Completion Type:Actual
Verification Date:May 2010
Last Changed Date:May 4, 2010
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Side effects of medications
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in craving during cue-induced brain activity
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in craving during limited-access alcohol consumption
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in craving from pre to post-alcohol ingestion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in craving as measured by the OCDS from pre-study to end of 5 day period
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Cue induced brain imaging -- Alcohol beverage cue minus neutral beverage cue activity in nucleus accumbens and insula
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Limited access alcohol consumption paradigm -- Total number of drinks consumed
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacological effects of alcohol consumption -- Average BAES stimulation score
Safety Issues:False
Outcome Type:Primary Outcome
Measure:"Natural" alcohol consumption period -- Total number of drinks consumed during the 5 day observation period
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:naltrexone (up to 50 mg/day) for 8 days; ondansetr

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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