Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369408
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2006-08-24
Brief Title:
Targeted Naltrexone for Problem Drinkers
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Targeted Naltrexone for Problem Drinkers
Status:
COMPLETED
Status Verified Date:
2011-06
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 determine whether naltrexone combined with brief coping skills therapy is effective in the treatment of heavy drinking
Detailed Description:
This is a 12-week placebo-controlled trial of naltrexone 50 mg orally in 163 problem drinkers Problem drinkers are those individuals whose drinking puts them at risk of a variety of psychosocial and medical problems including alcohol dependence but who are not physically dependent on alcohol They are estimated to comprise up to 20 of the general population The study employed a factorial design in which the effects of medication naltrexone vs placebo schedule of medication administration ie daily vs targeted and the interaction of these factors on drinking behavior were examined Targeted administration refers to the use of medication to cope with anticipated high-risk drinking situations
The daily monitoring using interactive voice response technology of mood desire to drink perceived self-efficacy and drinking behavior will make it possible to examine in depth the processes by which the study variables exert their effects Daily monitoring was performed using automated telephone interviews with in-person follow-up evaluations conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects
A pharmacogenetic analysis based on preliminary evidence showing that a functional polymorphism in the gene encoding the mu-opioid receptor OPRM1 affects response to naltrexone will serve to explore an important source of variation in the response to naltrexone treatment Exploratory analyses involving other potential genetic moderators of the response to naltrexone such as the gene encoding the delta opioid receptor OPRD1 will also be conducted as will the correlation of genotype data with other phenotypes
Careful evaluation of the study hypotheses will provide important information on the efficacy and mechanism of the effects of targeted naltrexone in problem drinkers This study will allow us to model effects across multiple levels of analysis in an effort to understand the psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms underlying the therapeutic effects of naltrexone in problem drinkers
The daily monitoring using interactive voice response technology of mood desire to drink perceived self-efficacy and drinking behavior will make it possible to examine in depth the processes by which the study variables exert their effects Daily monitoring was performed using automated telephone interviews with in-person follow-up evaluations conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects
A pharmacogenetic analysis based on preliminary evidence showing that a functional polymorphism in the gene encoding the mu-opioid receptor OPRM1 affects response to naltrexone will serve to explore an important source of variation in the response to naltrexone treatment Exploratory analyses involving other potential genetic moderators of the response to naltrexone such as the gene encoding the delta opioid receptor OPRD1 will also be conducted as will the correlation of genotype data with other phenotypes
Careful evaluation of the study hypotheses will provide important information on the efficacy and mechanism of the effects of targeted naltrexone in problem drinkers This study will allow us to model effects across multiple levels of analysis in an effort to understand the psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms underlying the therapeutic effects of naltrexone in problem drinkers
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 |
|---|---|---|---|
| NIAAA-KRA-P50-03510 | None | None | None |