Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00027079
First received: November 20, 2001
Last updated: December 7, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: ondansetron (Zofran) Drug: naltrexone (ReVia) Behavioral: Cognitive Behavioral Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Alcoholism
Drug Information available for:
Naltrexone
Naltrexone hydrochloride
Ondansetron hydrochloride
Ondansetron
U.S. FDA Resources
Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00027079 History of Changes |
| Other Study ID Numbers: | NIAAAJOH12964 |
| Study First Received: | November 20, 2001 |
| Last Updated: | December 7, 2007 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Ondansetron Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Antiemetics |
Autonomic Agents Gastrointestinal Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on May 23, 2013