Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342563
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2006-06-19
Brief Title:
Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Status:
COMPLETED
Status Verified Date:
2019-05
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 the study will be to evaluate the efficacy of mecamylamine in reducing alcohol consumption in smoking and non-smoking alcohol dependent patients
We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption than placebo We further hypothesize that mecamylamine will be effective in reducing both alcohol consumption and smoking in a subset of alcoholics who also smoke
We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption than placebo We further hypothesize that mecamylamine will be effective in reducing both alcohol consumption and smoking in a subset of alcoholics who also smoke
Detailed Description:
RESEARCH PLAN Although there are two FDA approved medications for the treatment of alcohol dependence naltrexone and disulfiram the robust efficacy of both compounds in reducing alcohol consumption has recently been called into question Given the high rates of alcohol dependence among the general population development and testing of novel medications is of great importance
Mecamylamine a noncompetitive NACh receptor antagonist has been shown to be useful in smoking cessation when used in combination with transdermal nicotine To our knowledge clinical studies examining the effectiveness of mecamylamine in alcoholism have not been conducted However there is evidence from animal research that mecamylamine can block the effects of alcohol Infusion of mecamylamine into the ventral tegmental area antagonized ethanol-induced dopamine release in rats More importantly mecamylamine decreased alcohol intake and preference in alcohol-preferring rats In two studies with healthy volunteers mecamylamine was effective in attenuating the euphoric effects of alcohol and reducing the craving for alcohol
This is the first study designed to test the clinical efficacy of mecamylamine in a sample of alcohol dependent patients who either do or do not smoke
For the proposed project we will recruit 60 treatment seeking patients between the ages of 18 and 60 who meet criteria for alcohol dependence and may or may not smoke Patients will be randomized into two groups 30 patients in each group one dose of mecamylamine 10mg or placebo in a double-blind fashion for 12 weeks Patients will be asked to come for follow up 3 months after completing the study Patients will be excluded if they take medications thought to influence drinking behavior have a significant underlying medical conditions such as cerebral renal thyroid hepatic or cardiac pathology have a history of glaucoma prostatic hypertrophy urethral obstruction cerebral arteriosclerosis pyloric stenosis or a history of hypersensitivity to mecamylamine or meet current criteria for Bipolar Disorders Schizophrenia and Schizophrenia-type Disorders Major Depression or Posttraumatic Stress Disorders PTSD Females who are pregnant or lactating will also be excluded
We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption than placebo among the alcohol dependent patients We further hypothesize that mecamylamine will be effective in reducing both alcohol consumption and smoking in a subgroup of alcoholics who also smoke
Mecamylamine a noncompetitive NACh receptor antagonist has been shown to be useful in smoking cessation when used in combination with transdermal nicotine To our knowledge clinical studies examining the effectiveness of mecamylamine in alcoholism have not been conducted However there is evidence from animal research that mecamylamine can block the effects of alcohol Infusion of mecamylamine into the ventral tegmental area antagonized ethanol-induced dopamine release in rats More importantly mecamylamine decreased alcohol intake and preference in alcohol-preferring rats In two studies with healthy volunteers mecamylamine was effective in attenuating the euphoric effects of alcohol and reducing the craving for alcohol
This is the first study designed to test the clinical efficacy of mecamylamine in a sample of alcohol dependent patients who either do or do not smoke
For the proposed project we will recruit 60 treatment seeking patients between the ages of 18 and 60 who meet criteria for alcohol dependence and may or may not smoke Patients will be randomized into two groups 30 patients in each group one dose of mecamylamine 10mg or placebo in a double-blind fashion for 12 weeks Patients will be asked to come for follow up 3 months after completing the study Patients will be excluded if they take medications thought to influence drinking behavior have a significant underlying medical conditions such as cerebral renal thyroid hepatic or cardiac pathology have a history of glaucoma prostatic hypertrophy urethral obstruction cerebral arteriosclerosis pyloric stenosis or a history of hypersensitivity to mecamylamine or meet current criteria for Bipolar Disorders Schizophrenia and Schizophrenia-type Disorders Major Depression or Posttraumatic Stress Disorders PTSD Females who are pregnant or lactating will also be excluded
We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption than placebo among the alcohol dependent patients We further hypothesize that mecamylamine will be effective in reducing both alcohol consumption and smoking in a subgroup of alcoholics who also smoke
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