Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218660
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2005-09-20
Brief Title:
Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Naltrexone and Psychosocial Treatments for the Treatment of Cocaine Dependence Complicated by Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2010-06
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:
The purpose of this study is to see whether naltrexone is safe and useful in preventing alcohol relapse as well as in decreasing craving for alcohol in people with a diagnosis of alcohol and cocaine dependence Naltrexone is approved by the Food and Drug Administration FDA for the treatment of alcohol dependence However the medication was not approved as yet at the dosage we will use in this study The dosage we will use for the study 150 mg is greater than the recommended dosage from the Physicians Desk Reference 50mg Unlike other medicines like Antabuse useful in the treatment of alcohol dependence naltrexone will not make you sick if you drink alcohol Rather people who are taking this medication have reported that it helps decrease the pleasure associated with drinking for them This study is being conducted because the medication Naltrexone has not been well studied in people with both alcohol and cocaine dependence so it is still investigational
We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy this may lead to reduced cocaine use We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use One type of psychotherapy CBT is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine andor alcohol use The other type of psychotherapy BRENDA will use focuses on strengthening motivation to recover from cocaine andor alcohol use and on developing techniques to handle possible barriers to recovery We seek to enroll 300 patients in the study
We believe that if we can reduce alcohol consumption through naltrexone and psychotherapy this may lead to reduced cocaine use We are also conducting this study to test two different types of psychotherapy as a method for reducing cocaine and alcohol use One type of psychotherapy CBT is designed to help people learn to cope with situations that put them at high risk for relapse to cocaine andor alcohol use The other type of psychotherapy BRENDA will use focuses on strengthening motivation to recover from cocaine andor alcohol use and on developing techniques to handle possible barriers to recovery We seek to enroll 300 patients in the study
Detailed Description:
The project will use a 2x2 design to assess the efficacy of naltrexone for treating subjects who are both cocaine and alcohol dependent and who will receive either CBT or BRENDA alone or in combination with naltrexone There will be 300 DSM-IV cocaine-alcohol dependent male and female subjects randomized to one of four groups 75 subjects per group Subjects will be randomized to either 150mgday naltrexone or placebo and to receive either CBT a type of cognitive behavior therapy derived from relapse prevention principles or a new primary-care basedmodel BRENDA comprised of strategies for enhancing motivation and treatment compliance All subjects will receive one of the four combinations of medication and psychosocial treatment The length of the study for each subject includes one week of screeningbaseline assessments 12 weeks of double-blind placebo-controlled naltrexone treatment combined with one of two psychosocial treatments and a 6-month and 12-month follow-up visit Following successful completion of detoxification abstinence from alcohol and cocaine for 7 days informed consent will be signed and Week 1 will be devoted to completing screening and baseline measures In Week 2 subjects will be randomly assigned to medication psychosocial treatment combination Following completion of the 12-week double-blind treatment trial subjects will be evaluated at 6-month and 12-months post-treatment 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 |
|---|---|---|---|
| P60-5186-1 | US NIH GrantContract | None | httpsreporternihgovquickSearchP60DA005186 |
| P60DA005186 | NIH | None | None |