|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | NCT00382642 |
Purpose
The purpose of this study is to learn whether ondansetron is safe and effective in the treatment of alcohol dependence. We also want to learn whether the study drug ondansetron combined with Cognitive Behavioral Therapy will assist researchers to determine whether having a certain gene is responsible for determining how a person benefits or does not benefit from the use of ondansetron for alcohol dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Ondansetron + Cognitive Behavioral Therapy Drug: Placebo + Cognitive Behavioral Therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pharmacological Treatment for Alcoholism |
| Enrollment: | 283 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ondansetron
Arm 1 = Ondansetron 4 mcg/kg b.i.d.+ Cognitive behavioral therapy
|
Drug: Ondansetron + Cognitive Behavioral Therapy
13 week outpatient trial
Other Name: Zofran
|
|
Placebo Comparator: Placebo
Arm 2 = Placebo + Cognitive behavioral therapy
|
Drug: Placebo + Cognitive Behavioral Therapy
13 week outpatient trial
Other Name: Sugar Pill
|
This is a 13 week outpatient clinical trial. Participants will either receive ondansetron or placebo and behavioral therapy. There is a 1, 2, and 3 month post-study follow up visit.Screening for this study is initially done over the telephone and takes 15-20 minutes. If participants are eligible after the initial screen, they will be invited to come in for a more thorough in house screen which takes about 5 to 6 hours. The screening will include a physical exam, review of medical, alcohol and drug histories and blood collection. If participants are found to be eligible after the in house screen, they will be enrolled in the 13 week outpatient clinical trial.
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 Center for Addiction Research and Education | |
| Charlottesville, Virginia, United States, 22911 | |
| Principal Investigator: | Bankole Johnson, M.D., Ph.D. | University of Virginia |
More Information
| Responsible Party: | Bankole Johnson, Chair of Psychiatry and NB Sciences, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00382642 History of Changes |
| Other Study ID Numbers: | R01AA10522-11, R01AA010522 |
| Study First Received: | September 28, 2006 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
alcoholism, alcohol disorder, drinking,alcohol |
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
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 |