Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320047
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2006-04-28
Brief Title:
Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Effects of Baclofen on Binge Eating in Bulimia Nervosa and Binge Eating Disorder
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of the drug baclofen in reducing binge eating and associated food cravings in people with bulimia nervosa or binge eating disorder
Detailed Description:
Bulimia nervosa BN and binge eating disorder BED are serious eating disorders that are characterized by frequent uncontrolled eating binges Binge eating is associated with both psychological and physical health problems such as depression obesity stomach problems and heart problems Treatment options for binge eating however are limited Baclofen a drug that enhances the GABA-B neurotransmitters ability to inhibit neuronal activity in the brain is commonly used as a muscle relaxant It has also been shown however to have positive effects on binge eating when used in animals and on substance abuse when used in humans This study will evaluate the effectiveness of baclofen in reducing binge eating and associated food cravings in people with BN or BED
People interested in participating in this study will first report to the study site for two initial visits which will involve blood tests and interviews regarding medical history If eligible participants will take part in this 13-week open-label study Participants will take baclofen 3 times a day before meals for 10 weeks Baclofen dosages will be low to begin followed by a gradual increase over a 2-week period Upon reaching the maximum tolerated dose of baclofen participants will continue at this dosage level until Week 11 at which time the dose will be gradually decreased If any serious side effects occur baclofen dosage will be decreased to the previous tolerated dosage level Participants will also keep a daily record of any episodes of binge eating Study visits will be held biweekly At each visit participants will be interviewed by a psychiatrist about their mental health history and eating patterns and will fill out questionnaires about their eating habits emotional states and any side effects Phone interviews will be conducted during the weeks in between study visits
People interested in participating in this study will first report to the study site for two initial visits which will involve blood tests and interviews regarding medical history If eligible participants will take part in this 13-week open-label study Participants will take baclofen 3 times a day before meals for 10 weeks Baclofen dosages will be low to begin followed by a gradual increase over a 2-week period Upon reaching the maximum tolerated dose of baclofen participants will continue at this dosage level until Week 11 at which time the dose will be gradually decreased If any serious side effects occur baclofen dosage will be decreased to the previous tolerated dosage level Participants will also keep a daily record of any episodes of binge eating Study visits will be held biweekly At each visit participants will be interviewed by a psychiatrist about their mental health history and eating patterns and will fill out questionnaires about their eating habits emotional states and any side effects Phone interviews will be conducted during the weeks in between study visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DNBBS 72-NBR | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH065024 |
| R21MH065024 | NIH | None | None |