Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249431
Status:
TERMINATED
Last Update Posted:
2017-10-27
First Post:
2005-11-03
Brief Title:
Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Pilot Study of Sertraline Plus Relapse Prevention Therapy RP for the Treatment of Pathological Gambling With Comorbid Abuse or Dependence
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to recruit patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pathological gamblers often are also dependent on alcohol and clinically depressed Sertraline Zoloft is currently used to treat depression panic disorder and obsessive-compulsive disorder The purpose of this trial is to determine the effectiveness of sertraline used in combination with relapse prevention therapy in decreasing gambling behavior and alcohol consumption in individuals with a diagnosis of pathological gambling and alcohol abuse or dependence
Detailed Description:
Alcohol abuse and depression commonly occur in conjunction with pathological gambling Sertraline Zoloft is a selective serotonin reuptake inhibitor SSRI currently used to treat depression panic disorder and obsessive-compulsive disorder The purpose of this trial is to determine the effectiveness of sertraline combined with relapse prevention therapy in decreasing gambling behavior and alcohol abuse
Participants in this 10-week trial will be randomly assigned to receive either relapse prevention RP therapy and sertraline or RP therapy and a placebo Participants will begin taking 25 mg of either sertraline or placebo in a single morning dose for one week If after one week participants do not show improvement the dose will increase to 50 mg per day during Week 2 and will increase by 50 mg per day every week thereafter to a maximal dose of 200 mg per day
Weekly hour-long study visits will include a medication evaluation RP therapy and questionnaires In addition evaluations at baseline Week 5 and Week 10 will include pathological gambling and depression ratings urine drug screens and biochemical measures of alcohol consumption and liver function All other weekly study visits will include evaluation of side effects an interview on alcohol use measures related to obsessive-compulsive drinking and assessments of vital signs and concomitant medications
Participants in this 10-week trial will be randomly assigned to receive either relapse prevention RP therapy and sertraline or RP therapy and a placebo Participants will begin taking 25 mg of either sertraline or placebo in a single morning dose for one week If after one week participants do not show improvement the dose will increase to 50 mg per day during Week 2 and will increase by 50 mg per day every week thereafter to a maximal dose of 200 mg per day
Weekly hour-long study visits will include a medication evaluation RP therapy and questionnaires In addition evaluations at baseline Week 5 and Week 10 will include pathological gambling and depression ratings urine drug screens and biochemical measures of alcohol consumption and liver function All other weekly study visits will include evaluation of side effects an interview on alcohol use measures related to obsessive-compulsive drinking and assessments of vital signs and concomitant medications
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 |
|---|---|---|---|
| 5K23DA000482 | NIH | None | httpsreporternihgovquickSearch5K23DA000482 |