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| Sponsor: | Bankole Johnson |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by (Responsible Party): | Bankole Johnson, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00768508 |
Purpose
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: Ondansetron + Cognitive Behavioral Therapy Drug: Naltrexone + Cognitive Behavioral Therapy Drug: Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day for 12 weeks + Cognitive Behavioral Therapy Other: Placebo for 12 weeks + Cognitive Behavioral Therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Combined Pharmacotherapies for Alcoholism |
| Estimated Enrollment: | 320 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ondansetron
Ondansetron 4 ug/kg b.i.d.
|
Drug: Ondansetron + Cognitive Behavioral Therapy
Ondansetron 4 ug/kg b.i.d.for 12 weeks
Other Name: Zofran
|
|
Experimental: Naltrexone
Naltrexone 50 mg/day
|
Drug: Naltrexone + Cognitive Behavioral Therapy
Naltrexone 50 mg/day for 12 weeks
Other Name: Revia
|
|
Experimental: Ondansetron + Naltrexone
Combination of Ondansetron 4 ug/kg b.i.d. and Naltrexone 50 mg/day
|
Drug: Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day for 12 weeks + Cognitive Behavioral Therapy
Combination of ondansetron and naltrexone
Other Name: Zofran and Revia
|
| Placebo Comparator: Placebo |
Other: Placebo for 12 weeks + Cognitive Behavioral Therapy
Placebo comparator
Other Name: sugar pill
|
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Virginia | |
| UVA CARE | |
| Charlottesville, Virginia, United States, 22911 | |
| UVA CARE Richmond | |
| Richmond, Virginia, United States, 23294 | |
| Principal Investigator: | Bankole Johnson, DSc,MD,PhD | University of Virginia |
More Information
| Responsible Party: | Bankole Johnson, Chair of Psychiatry and NB Sciences, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00768508 History of Changes |
| Other Study ID Numbers: | 12790, R01AA012964 |
| Study First Received: | October 6, 2008 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Alcohol Alcohol Dependence Alcoholism |
|
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 |